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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Lifescan, Inc. — Predicate Candidate Screening

42 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

80 daysmedian FDA review time
224 days90th percentile
42clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K132618ONETOUCH REVEALLifescan, Inc.2013-12-161170
K120558ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATIONLifescan, Inc.2013-02-073490
K093745ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.2011-02-114340
K082590SYMPHONY METER REMOTELifescan, Inc.2008-12-171000
K082513ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.2008-10-22500
K081318ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAMLifescan, Inc.2008-06-09280
K073231ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.2008-04-181550
K072543ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.2007-10-05251
K062195MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSLifescan, Inc.2006-08-16154
K061118ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.2006-05-19280
K053529ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.2006-01-17290
K043197ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORINLifescan, Inc.2005-05-201833
K031472ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPSLifescan, Inc.2003-08-05880
K024194ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORINGLifescan, Inc.2003-02-07495
K023832SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.2002-12-13251
K023194SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMLifescan, Inc.2002-10-24292
K022922HARMONY INR MONITORING SYSTEMLifescan, Inc.2002-09-30260
K022724SURESTEP BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.2002-09-12273
K021819ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.2002-08-23801
K021943ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.2002-06-28310
K001699RUBICON PROTHROMBIN TIME MONITORING SYSTEMLifescan, Inc.2001-05-153470
K001441SATURN BLOOD GLUCOSE MONITORING TEST STRIPLifescan, Inc.2000-12-182240
K984261SURESTEP BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.1999-05-211750
K984527IN TOUCH DIABETES MANAGEMENT SOFTWARELifescan, Inc.1999-04-291291
K974451ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.1998-01-26620
K972473ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DLifescan, Inc.1997-12-161680
K970556SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.1997-05-12881
K971014LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONSLifescan, Inc.1997-04-23340
K950816ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.1995-07-031310
K950727ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEMLifescan, Inc.1995-06-011050
K942455LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.1995-03-243050
K923544ONE TOUCH TEST STRIPSLifescan, Inc.1992-12-031400
K922888ONE TOUCH IIB BLOOD GLUCOSE METERLifescan, Inc.1992-09-15910
K913357ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYSTLifescan, Inc.1991-11-071010
K895911ONE TOUCH II METERLifescan, Inc.1989-11-08290
K894804SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)Lifescan, Inc.1989-09-28620
K864322MPX SYSTEM, GLUCOSE TEST SYSTEMLifescan, Inc.1987-02-251140
K822699GLUCOSCAN METER MODEL IILifescan, Inc.1982-11-05590
K822697GLUCOSCAN TEST STRIPSLifescan, Inc.1982-09-30230
K822698GLUCOSCAN CONTROLSLifescan, Inc.1982-09-30230
K810993GLUCOSCAN TEST STRIPSLifescan, Inc.1981-04-29160
K810665GILUCOCHEK REFLECTANCE METERLifescan, Inc.1981-04-17370

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda