Company ยท US
Lifescan, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2013. Name variants (Inc, Corp, punctuation) are merged.
42510(k) clearances (0 in 12 months)
27recalls (0 in 12 months)
23recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 30 |
| CGA | Glucose Oxidase, Glucose | 26 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 5 |
| GJS | Test, Time, Prothrombin | 2 |
| F | 1 | |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 |
| LFR | Glucose Dehydrogenase, Glucose | 1 |
| LZG | Pump, Infusion, Insulin | 1 |
| MRZ | Accessories, Pump, Infusion | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 16, 2013 | K132618 | ONETOUCH REVEAL Lifescan, Inc. | MRZ |
| Feb 7, 2013 | K120558 | ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION Lifescan, Inc. | NBW |
| Feb 11, 2011 | K093745 | ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | NBW |
| Dec 17, 2008 | K082590 | SYMPHONY METER REMOTE Lifescan, Inc. | LZG |
| Oct 22, 2008 | K082513 | ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | NBW |
| Jun 9, 2008 | K081318 | ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM Lifescan, Inc. | NBW |
| Apr 18, 2008 | K073231 | ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | NBW |
| Oct 5, 2007 | K072543 | ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | NBW |
| Aug 16, 2006 | K062195 | MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | NBW |
| May 19, 2006 | K061118 | ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | NBW |
| Jan 17, 2006 | K053529 | ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | NBW |
| May 20, 2005 | K043197 | ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | CGA |
| Aug 5, 2003 | K031472 | ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS Lifescan, Inc. | CGA |
| Feb 7, 2003 | K024194 | ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS Lifescan, Inc. | NBW |
| Dec 13, 2002 | K023832 | SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | NBW |
| Oct 24, 2002 | K023194 | SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM Lifescan, Inc. | CGA |
| Sep 30, 2002 | K022922 | HARMONY INR MONITORING SYSTEM Lifescan, Inc. | GJS |
| Sep 12, 2002 | K022724 | SURESTEP BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | NBW |
| Aug 23, 2002 | K021819 | ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | NBW |
| Jun 28, 2002 | K021943 | ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | CGA |
| May 15, 2001 | K001699 | RUBICON PROTHROMBIN TIME MONITORING SYSTEM Lifescan, Inc. | GJS |
| Dec 18, 2000 | K001441 | SATURN BLOOD GLUCOSE MONITORING TEST STRIP Lifescan, Inc. | CGA |
| May 21, 1999 | K984261 | SURESTEP BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | CGA |
| Apr 29, 1999 | K984527 | IN TOUCH DIABETES MANAGEMENT SOFTWARE Lifescan, Inc. | CGA |
| Jan 26, 1998 | K974451 | ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | CGA |
| Dec 16, 1997 | K972473 | ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK Lifescan, Inc. | CGA |
| May 12, 1997 | K970556 | SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | CGA |
| Apr 23, 1997 | K971014 | LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS Lifescan, Inc. | JJX |
| Jul 3, 1995 | K950816 | ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | CGA |
| Jun 1, 1995 | K950727 | ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM Lifescan, Inc. | CGA |
| Mar 24, 1995 | K942455 | LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. | CGA |
| Dec 3, 1992 | K923544 | ONE TOUCH TEST STRIPS Lifescan, Inc. | CGA |
| Sep 15, 1992 | K922888 | ONE TOUCH IIB BLOOD GLUCOSE METER Lifescan, Inc. | CGA |
| Nov 7, 1991 | K913357 | ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST Lifescan, Inc. | CGA |
| Nov 8, 1989 | K895911 | ONE TOUCH II METER Lifescan, Inc. | CGA |
| Sep 28, 1989 | K894804 | SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED) Lifescan, Inc. | JJX |
| Feb 25, 1987 | K864322 | MPX SYSTEM, GLUCOSE TEST SYSTEM Lifescan, Inc. | CGA |
| Nov 5, 1982 | K822699 | GLUCOSCAN METER MODEL II Lifescan, Inc. | CGA |
| Sep 30, 1982 | K822698 | GLUCOSCAN CONTROLS Lifescan, Inc. | JJX |
| Sep 30, 1982 | K822697 | GLUCOSCAN TEST STRIPS Lifescan, Inc. | CGA |
| Apr 29, 1981 | K810993 | GLUCOSCAN TEST STRIPS Lifescan, Inc. | CGA |
| Apr 17, 1981 | K810665 | GILUCOCHEK REFLECTANCE METER Lifescan, Inc. | JJQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2013 | Lifescan Inc LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902.
Testing of Blood Glucose Levels. Terminated |
JJX | K072543 |
| Apr 17, 2013 | Lifescan Inc LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603.
Testing of Blood Glucose Levels. Terminated |
JJX | K062195 |
| Apr 12, 2013 | Lifescan Inc All OneTouch Verio IQ Blood Glucose Meters sold as:
Verio IQ System Kits - Meter;
Verio IQ Starter kits - Meter;
Verio IQ Warranty Meter.
Product Usage: The OneTouch VerioIQ Blood Glucose Monitorin Terminated |
NBW | None listed |
| Apr 2, 2012 | Lifescan Inc OneTouch Verio IQ Blood Glucose Monitoring System Kit;
One Touch Verio IQ Blood Glucose IQ Blood Glucose Monitoring Starter Kit;
One Touch Verio IQ Blood Glucose Monitoring Warranty Kit.
Distributed Terminated |
LFR | K110637 |
| Jul 15, 2011 | Lifescan Inc OneTouch Delica Lancing Device;
LifeScan Inc., Milpitas, CA
Testing of Blood Glucose Levels Terminated |
F | None listed |
| Oct 1, 2010 | Lifescan Inc One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc., Milpitas, CA. Terminated |
NBW | K062195 |
| Jul 17, 2010 | Lifescan Inc OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose Meters, in 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico
Terminated |
NBW | K023194 |
| Jul 17, 2010 | Lifescan Inc OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood Glucose Meters, in 100 count and 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by Terminated |
NBW | K022724 |
| Mar 17, 2009 | Lifescan Inc OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, manufactured by LifeScan Inc., Milpitas, CA Terminated |
NBW | K022724 |
| Nov 21, 2008 | Lifescan Inc One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count.
Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Terminated |
NBW | K062195 |
| Apr 8, 2008 | Lifescan Inc LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan Inc, Milpitas, CA 95037. Terminated |
NBW | K984527 |
| Aug 16, 2007 | Lifescan Inc One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200 Terminated |
FMK | None listed |
| Jul 13, 2007 | Lifescan Inc OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch UltraMini, e) OneTouch UltraSma Terminated |
NBW | K062195 |
| Jan 5, 2007 | Lifescan Inc LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50 strips per package,
Distributed and Manufactured by: LifeScan, Inc.,
1000 Gibraltar Drive, Milpitas, CA 95037 Terminated |
CGA | K023194 |
| Jan 5, 2007 | Lifescan Inc LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips per package,
Distributed and Manufactured by: LifeScan, Inc.,
1000 Gibraltar Drive, Milpitas, CA 95037 Terminated |
NBW | K022724 |
| Jan 24, 2006 | Lifescan Inc LifeScan OneTouch Ultra Test strips, lot number 2528640 Terminated |
CGA | K043197 |
| Dec 8, 2005 | Lifescan Inc LifeScan brand OneTouch Ultra Test strips, 25 strips per vial Terminated |
NBW | K043197 |
| Dec 8, 2005 | Lifescan Inc LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter Terminated |
NBW | K043197 |
| Dec 8, 2005 | Lifescan Inc LifeScan OneTouch SureSoft Lancing Device, single use lancing device. Terminated |
NBW | None listed |
| Oct 28, 2005 | Lifescan Inc Lifescan OneTouch SureStep Meter Blood Glucose monitoring system,Product is distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037 Terminated |
CGA | K023832 |
| Sep 29, 2005 | Lifescan Inc LifeScan brand OneTouch Ultra Meter - Owner''s Booklet;
Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037 Terminated |
NBW | K024194 |
| Jul 13, 2005 | Lifescan Inc LifeScan brand One Touch UltraSmart Meter Owners Booklet AW 060-788-01A;
All One Touch UltraSmart Meters shipped with OneTouch UltraSmart Owner''s Booklet AW 060-788-01A are affected by this Field Co Terminated |
NBW | K021819 |
| Jun 14, 2005 | Lifescan Inc LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc.,
1000 Gibraltar Drive, Milpitas, CA 95037 Terminated |
CGA | K024194 |
| May 17, 2005 | Lifescan Inc LifeScan Brand InDuo Blood Glucose Meter Terminated |
NBW | K024194 |
| May 17, 2005 | Lifescan Inc LifeScan brand OneTouch FastTake Blood Glucose Meter Terminated |
NBW | K024194 |
| May 17, 2005 | Lifescan Inc LifeScan brand OneTouch Ultra Blood Glucose Meter Terminated |
NBW | K024194 |
| Mar 12, 2003 | Lifescan Inc OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use) Terminated |
CGA | K970556 |