Company ยท US
Abbott Diabetes Care, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2026. Name variants (Inc, Corp, punctuation) are merged.
40510(k) clearances (1 in 12 months)
57recalls (4 in 12 months)
32recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 41 |
| MDS | Sensor, Glucose, Invasive | 21 |
| QLG | Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems | 15 |
| LFR | Glucose Dehydrogenase, Glucose | 7 |
| LZG | Pump, Infusion, Insulin | 3 |
| QBJ | Integrated Continuous Glucose Monitoring System, Factory Calibrated | 3 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 2 |
| PZE | Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| SBH | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter | 1 |
| SJD | Integrated Continuous Glucose Ketone Monitoring System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 25, 2026 | DEN250049 | Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System Abbott Diabetes Care | SJD |
| Jun 7, 2024 | K233861 | Libre Rio Continuous Glucose Monitoring System Abbott Diabetes Care | SBH |
| Apr 23, 2024 | K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System Abbott Diabetes Care, Inc. | QBJ |
| Apr 13, 2023 | K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System Abbott Diabetes Care, Inc. | QBJ |
| Mar 3, 2023 | K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System Abbott Diabetes Care, Inc. | QBJ |
| Feb 21, 2023 | K223537 | FreeStyle Libre 2 System, FreeStyle Libre 3 System Abbott Diabetes Care, Inc. | QLG |
| May 26, 2022 | K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring System Abbott Diabetes Care, Inc. | QLG |
| May 26, 2022 | K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring System Abbott Diabetes Care, Inc. | QLG |
| Nov 22, 2021 | K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) Abbott Diabetes Care, Inc. | QLG |
| Aug 11, 2021 | K211102 | FreeStyle Libre 2 Flash Glucose Monitoring System Abbott Diabetes Care, Inc. | QLG |
| Jul 30, 2021 | K201761 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) Abbott Diabetes Care, Inc. | QLG |
| Jun 12, 2020 | K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System Abbott Diabetes Care, Inc. | QLG |
| Sep 27, 2017 | K171941 | FreeStyle Precision Neo Blood Glucose Test Strips Abbott Diabetes Care, Inc. | NBW |
| Feb 19, 2016 | K153330 | FreeStyle Precision Neo H Blood Glucose Monitoring System Abbott Diabetes Care, Inc. | NBW |
| Sep 30, 2015 | K142928 | FreeStyle Precision Neo Blood Glucose Monitoring System Abbott Diabetes Care, Inc. | NBW |
| Sep 30, 2014 | K140371 | FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) Abbott Diabetes Care, Inc. | NBW |
| Dec 24, 2013 | K132511 | FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM Abbott Diabetes Care, Inc. | NBW |
| Jun 27, 2013 | K130094 | FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM Abbott Diabetes Care | NBW |
| Mar 29, 2012 | K120568 | FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc. | NBW |
| Jun 15, 2010 | K092638 | FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 Abbott Diabetes Care, Inc. | NBW |
| May 14, 2010 | K092602 | FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System Abbott Diabetes Care, Inc. | NBW |
| Apr 16, 2009 | K083223 | RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01 Abbott Diabetes Care, Inc. | LFR |
| Feb 20, 2009 | K083225 | FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc. | LZG |
| Nov 26, 2008 | K081975 | RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) Abbott Diabetes Care, Inc. | NBW |
| Sep 5, 2008 | K080960 | PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS Abbott Diabetes Care, Inc. | NBW |
| Jan 11, 2008 | K071788 | AVIATOR INSULIN PUMP Abbott Diabetes Care, Inc. | LZG |
| Nov 1, 2007 | K070984 | THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS Abbott Diabetes Care, Inc. | LFR |
| Apr 10, 2007 | K070850 | FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc. | NBW |
| Dec 14, 2006 | K062770 | COPILOT HEALTH MANAGEMENT SYSTEM Abbott Diabetes Care, Inc. | NBW |
| Apr 21, 2006 | K060768 | PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS Abbott Diabetes Care, Inc. | JIN |
| Mar 9, 2006 | K051839 | FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001 Abbott Diabetes Care, Inc. | NBW |
| Dec 23, 2005 | K051041 | INSULIN PUMP Abbott Diabetes Care, Inc. | LZG |
| Aug 9, 2005 | K051802 | FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc. | NBW |
| Jun 27, 2005 | K050500 | FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc. | NBW |
| Dec 19, 2003 | K031260 | FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 Abbott Diabetes Care, Inc. | NBW |
| Jun 11, 2002 | K020866 | FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM Abbott Diabetes Care, Inc. | NBW |
| Dec 5, 2001 | K012014 | MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc. | NBW |
| Dec 5, 2000 | K000582 | FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 Abbott Diabetes Care, Inc. | LFR |
| May 5, 2000 | K994433 | CONNECT DATA MANAGEMENT SYSTEM Abbott Diabetes Care, Inc. | LFR |
| Jan 14, 2000 | K992684 | FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc. | LFR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2026 | Abbott Diabetes Care, Inc. FreeStyle Libre 3 Plus Sensor REF 72080-01
UDI-DI code: 00357599819002
The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. Open, Classified |
QLG | K212132 |
| Jan 14, 2026 | Abbott Diabetes Care, Inc. FreeStyle Libre 3 Plus Sensor REF 78769-01
UDI-DI code: 00357599843014
The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. Open, Classified |
QLG | K233537 |
| Jan 14, 2026 | Abbott Diabetes Care, Inc. FreeStyle Libre 3 Plus Sensor REF 78768-01
UDI-DI code: 00357599844011
The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. Open, Classified |
QLG | K233537 |
| Jan 14, 2026 | Abbott Diabetes Care, Inc. FreeStyle Libre 3 Sensor REF 72081-01
UDI-DI code: 00357599818005
The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. Open, Classified |
QLG | K212132 |
| Aug 27, 2024 | Abbott Diabetes Care, Inc. FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System Open, Classified |
QLG | K212132 |
| Jan 16, 2024 | Abbott Diabetes Care, Inc. FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System Completed |
QLG | K213996 |
| Aug 17, 2023 | Abbott Diabetes Care, Inc. FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System Open, Classified |
QLG | K193371 |
| Apr 6, 2023 | Abbott Diabetes Care, Inc. FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System Open, Classified |
QLG | K193371 |
| Apr 6, 2023 | Abbott Diabetes Care, Inc. FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System Open, Classified |
PZE | None listed |
| Apr 6, 2023 | Abbott Diabetes Care, Inc. FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System Open, Classified |
PZE | None listed |
| Feb 28, 2020 | Abbott Diabetes Care, Inc. FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810 Terminated |
JIN | K060768 K070984 |
| Feb 28, 2020 | Abbott Diabetes Care, Inc. Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653 Terminated |
NBW | K081975 |
| Feb 28, 2020 | Abbott Diabetes Care, Inc. Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144 Terminated |
NBW | K040814 |
| Mar 18, 2014 | Abbott Diabetes Care, Inc. FreeStyle Flash Blood Glucose Monitors System.
Meter made in China;
Distributed by TheraSense, Alameda, CA
The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle C Terminated |
NBW | K092638 |
| Mar 18, 2014 | Abbott Diabetes Care, Inc. FreeStyle Blood Glucose Monitors System.
For in vitro diagnostic use only. Store at room
temperature below 86 degrees F (30 degrees C). Use test strips
only within the system operating temperature
ran Terminated |
NBW | K092638 |
| Dec 17, 2013 | Abbott Diabetes Care, Inc. FreeStyle Lite Blood Glucose Test Strips;
For in vitro diagnostic testing.
50 count; 100 count Product of Ireland;
UPC 6 99073 70819 9; - 50 count
UPC 6 99073 70822 9 - 50 count
UPC 6 99073 71026 0 Terminated |
NBW | K092602 |
| Dec 17, 2013 | Abbott Diabetes Care, Inc. FreeStyle Blood Glucose Test Strips;
For in vitro diagnostic testing.
50 count
UPC 6 99073 12050 2;
Freestyle Blood Glucose Test Strips; for Institutional Use only
50 count:
UPC 6 99073 70792 5
Manu Terminated |
NBW | K092602 |
| May 9, 2013 | Abbott Diabetes Care, Inc. FreeStyle InsuLinx Blood Glucose Monitoring System:
For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips.
Abbott Diabetes Care, Inc.
1360 South Loop Road
Alameda, CA 94502 U Terminated |
NBW | K120568 |
| Feb 15, 2011 | Abbott Diabetes Care, Inc. FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose Monitoring System Test Strips, for use with FreeStyle and FreeStyle Lite Test Strips respectively, 100 count, man Terminated |
NBW | K051839 |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care, ReliOn Ultima Blood Glucose Test ; Terminated |
NBW | K083223 |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care, Precision Xtra Blood Glucose Test Strips;
Precision Xtra Blood Glucose & Ketone Monitoring System;
Precision G3b Smartblue Blood Glucose Test Strips; Terminated |
NBW | K051213 |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care, Precision Point of Care Blood Glucose Test Strips; Terminated |
NBW | K070984 |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care, Optium Blood Glucose Test Strips; Terminated |
NBW | K051213 |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care, MediSense Optium Blood Glucose Test Strips;
MediSense Optium Blood Glucose Electrodes; Terminated |
NBW | K051213 |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care Optium EZ Blood Glucose Test Strips; Terminated |
NBW | K081975 |
| Feb 9, 2011 | Abbott Diabetes Care, Inc. Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips Terminated |
NBW | K070984 |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, Clinical Transmitter, Abbott Item Number: PRT 03831-091, distributed by Abbott Diabetes Care Inc, Alameda, CA.
Medical device indicated for con Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, Assy, Transmitter Poly Contac, Abbott Item Number: PRT 03831-002, distributed by Abbott Diabetes Care Inc, Alameda, CA.
Medical device indicated Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, ABB Transmitter Navigator. Abbott Item Number: PRT 03831-001, distributed by Abbott Diabetes Care Inc, Alameda, CA.
Medical device indicated f Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging. Abbott Item Number: PRT 03415-010, distributed by Abbott Diabetes Care Inc, Alameda, CA.
Medical device indic Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, System Kit, Business 1, (Orange). Abbott Item Number: PRT 03415-001, distributed by Abbott Diabetes Care Inc, Alameda, CA.
Medical device indi Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MG EMEA and System Kit MMOL, EMEA. Abbott Item Number 71036-02, distributed by Abbott Diabetes Care Inc, Alameda Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MMOL EMEA. Abbott Item Number 71036-01, distributed by Abbott Diabetes Care Inc, Alameda, CA.
Medical device in Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MMOL (EMEA) SV. Abbott Item Number 70966-04, distributed by Abbott Diabetes Care Inc, Alameda, CA.
Medical device Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System, Business 1, MMOL (EMEA) UK. Abbott Item Number 70966-03, distributed by Abbott Diabetes Care Inc, Alameda, CA.
Medic Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System, Business 1, MMOL. Abbott Item Number 70966-02, distributed by Abbott Diabetes Care Inc, Alameda, CA.
Medical device Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, ABB NAV Dutch System Kit CE RE, AND ABB SYSTEM KIT, MMOL, EMEA AND ABB09 Dutch Kit New LCD. Abbot Item Number 70966-01, distributed by Abbott L Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit Business I, MG, and System Kit MG (EMEA) FR, PACK. Abbott Item Number 70965-03, distributed by Abbott Diabetes Car Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit Business I, MG,(E). Abbott Item Number 70965-02, distributed by Abbott Diabetes Care Inc, Alameda, CA.
Medical dev Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB System Kit MG, EMEA, DE. Abbott Item Number 70965-01, distributed by Abbott Diabetes Care Inc, Alameda, CA.
Medical device Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, Reorder/Warranty Kit EMEA, Abbott Item Number 70791-20, distributed by Abbott Diabetes Care Inc, Alameda, CA.
Medical device in Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, Replacement Kit, Transmitter, Abbott Item Number 70791-02, distributed by Abbott Diabetes Care Inc, Alameda, CA.
Medical device Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB Warranty Kit Xmitter Nav, Abbott Item Number 70791-01, distributed by Abbott Diabetes Care Inc, Alameda, CA.
Medical device Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, SYSTEM KIT PACKAGING , Abbott Item Number 70684-03, distributed by Abbott Diabetes Care Inc, Alameda, CA.
Medical device indic Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, SYSTEM KIT PACKAGING ORANGE, Abbott Item Number 70684-02, distributed by Abbott Diabetes Care Inc, Alameda, CA.
Medical device Terminated |
MDS | None listed |
| Apr 30, 2010 | Abbott Diabetes Care, Inc. Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB SYSTEM KIT(ORANGE)PACK NAV, Abbott Item Number 70684-01, distributed by Abbott Diabetes Care Inc, Alameda, CA.
Medical devi Terminated |
MDS | None listed |
| Sep 1, 2009 | Abbott Diabetes Care, Inc. FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with FreeStyle Lite Blood Glucose Meters and FreeStyle Freedom Lite Blood Glucose Meters, Part Number 70822-02, man Terminated |
NBW | K070850 |
| May 20, 2009 | Abbott Diabetes Care, Inc. Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, Part Number: 70789-01.
The product is manufactured by Benchmark Electronics, 3535 Technology Drive NW, Roch Terminated |
MDS | None listed |
| Sep 11, 2008 | Abbott Diabetes Care, Inc. Abbott FreeStyle Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring Meter Terminated |
LFR | K992684 |
| Feb 14, 2008 | Abbott Diabetes Care, Inc. Blood glucose meter, marketed with multiple brand names including: Precision Xtra New and Improved meter, Precision Xceed meter, Optium Xceed meter, Optium meter, ReliOn Ultima meter, Rite Aid meter, Terminated |
NBW | K033845 K040814 |
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