Company ยท US
Roche Diabetes Care, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2023. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
29recalls (0 in 12 months)
22recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 17 |
| NDC | Calculator, Drug Dose | 7 |
| LFR | Glucose Dehydrogenase, Glucose | 5 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 4 |
| LZG | Pump, Infusion, Insulin | 3 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 2 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 2 |
| FPA | Set, Administration, Intravascular | 1 |
| QFG | Alternate Controller Enabled Insulin Infusion Pump | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 13, 2023 | K232509 | Accu-Chek Safe-T-Pro Uno Lancing Device Roche Diabetes Care, Inc. | FMK |
| Nov 13, 2023 | K232488 | Accu-Chek Safe-T-Pro Plus Lancing Device Roche Diabetes Care, Inc. | FMK |
| Aug 10, 2023 | K213134 | Accu-Chek Solo micropump system with interoperable technology Roche Diabetes Care GmbH, DE | QFG |
| Aug 10, 2023 | K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system Roche Diabetes Care GmbH, DE | NBW |
| May 19, 2022 | K220849 | Accu-Chek Safe-T-Pro Plus Lancing Device Roche Diabetes Care, Inc. | FMK |
| May 6, 2022 | K203711 | IWL2020 Blood Glucose Monitoring System Roche Diabetes Care, Inc. | NBW |
| Apr 29, 2022 | K220608 | Accu-Chek FastClix Blood Lancing System Roche Diabetes Care, Inc. | QRL |
| Apr 5, 2022 | K220364 | Accu-Chek Safe-T-Pro Uno Lancing Device Roche Diabetes Care, Inc. | FMK |
| Feb 17, 2022 | K214022 | Accu-Chek Softclix Blood Lancing System Roche Diabetes Care, Inc. | QRL |
| Dec 13, 2018 | K181131 | Accu-Chek Guide Me Blood Glucose Monitoring System Roche Diabetes Care | NBW |
| Aug 31, 2016 | K160944 | ACCU-CHEK Guide Blood Glucose Monitoring System Roche Diabetes Care, Inc. | NBW |
| Jun 3, 2015 | K150910 | ACCU-CHEK Connect Diabetes Management App Roche Diabetes Care, Inc. | NDC |
| Nov 16, 2012 | K122686 | ACCU-CHEK ULTRAFLEX INFUSION SET Roche Diabetes Care AG, CH | FPA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2024 | Roche Diabetes Care, Inc. Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control Open, Classified |
NBW | K160944 |
| Mar 9, 2022 | Roche Diabetes Care, Inc. RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product. Terminated |
JQP | None listed |
| Jul 28, 2021 | Roche Diabetes Care, Inc. Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001 Open, Classified |
NBW | K121679 |
| Jul 28, 2021 | Roche Diabetes Care, Inc. Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001 Open, Classified |
LFR | K113137 |
| Jul 28, 2021 | Roche Diabetes Care, Inc. Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001 Open, Classified |
LFR | K133741 |
| Jul 28, 2021 | Roche Diabetes Care, Inc. Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001 Open, Classified |
LZG | K131029 |
| Dec 30, 2019 | Roche Diabetes Care, Inc. Blood Glucose Monitoring System, Model Number 08313202001
ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measu Terminated |
NBW | None listed |
| Dec 30, 2019 | Roche Diabetes Care, Inc. Blood Glucose Monitoring System, Model Number 08453063001
ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively mea Terminated |
NBW | None listed |
| Dec 30, 2019 | Roche Diabetes Care, Inc. Blood Glucose Monitoring System, Model Number 08453071001
ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively mea Terminated |
NBW | None listed |
| Dec 30, 2019 | Roche Diabetes Care, Inc. Blood Glucose Monitoring System, Model Number 07400942001
ACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure Terminated |
NBW | None listed |
| Dec 30, 2019 | Roche Diabetes Care, Inc. Blood Glucose Monitoring System, Model Number 07400926001
ACCU-CHEK GUIDE RETAIL KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure gl Terminated |
NBW | None listed |
| Dec 30, 2019 | Roche Diabetes Care, Inc. Blood Glucose Monitoring System, Model Number 07400870001
ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure gl Terminated |
NBW | K160944 |
| Dec 11, 2019 | Roche Diabetes Care, Inc. ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System
Catalog Number: 06453970020 Terminated |
NBW | None listed |
| Dec 11, 2019 | Roche Diabetes Care, Inc. Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System
Catalog Number: 06908217001 Terminated |
NBW | K131029 |
| Dec 11, 2019 | Roche Diabetes Care, Inc. Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System
Catalog Number: 06908349001 Terminated |
NBW | K131029 |
| Sep 30, 2019 | Roche Diabetes Care, Inc. Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary w Terminated |
NBW | K133862 |
| Sep 30, 2019 | Roche Diabetes Care, Inc. Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whol Terminated |
NBW | K133862 |
| May 3, 2019 | Roche Diabetes Care, Inc. Accu-Chek Connect Diabetes Management App Terminated |
NDC | K150910 |
| May 9, 2018 | Roche Diabetes Care, Inc. Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001
Product Usage:
The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitat Terminated |
LFR | K131029 |
| May 9, 2018 | Roche Diabetes Care, Inc. Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001
Product Usage:
The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitative Terminated |
LFR | K131029 |
| May 9, 2018 | Roche Diabetes Care, Inc. Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001
Product Usage:
The Accu-Chek Aviva Plus test strips are for use with t Terminated |
LFR | K131029 |
| Jun 8, 2017 | Roche Diabetes Care, Inc. Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017 Terminated |
NDC | K150910 |
| Jun 8, 2017 | Roche Diabetes Care, Inc. Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017
The Accu-Chek Connect Diabetes Mana Terminated |
NDC | K150910 |
| Mar 14, 2017 | Roche Diabetes Care, Inc. Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android
Product Usage:
This is a digital product available for download direct to customers from the Apple App St Terminated |
NDC | K150910 |
| Jan 26, 2017 | Roche Diabetes Care, Inc. Accu-Chek Connect Diabetes Management App Terminated |
NDC | K150910 |
| Nov 16, 2016 | Roche Diabetes Care, Inc. Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016 Terminated |
NDC | K150910 |
| Jun 9, 2015 | Roche Diabetes Care, Inc. AccuChek Spirit insulin infusion pump. Terminated |
LZG | K042887 |
| Jun 9, 2015 | Roche Diabetes Care, Inc. AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System. Terminated |
LZG | K111353 |
| Apr 2, 2015 | Roche Diabetes Care, Inc. ACCU-CHEK Connect Diabetes Management App; Instruction Manual
Designed to transfer data for diabetes management. Terminated |
JQP | K141929 |