510(k) Report

FDA applicant

Lifescan, Inc.

Milpitas, CA42 decisions1981–201324 recalls

FDA records 42 decisions for Lifescan, Inc. (Milpitas, CA) from 1981 to 2013: 42 510(k) clearances. Most are in product codes CGA (Glucose Oxidase, Glucose) and NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 14 predicates, 9 of them its own earlier devices. 24 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Lifescan, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2007: 12008: 42011: 12013: 2
2007high 4 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2021

2007: 22008: 22010: 32013: 22021: 2
2007high 3 (2010) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Lifescan, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lifescan, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CGAGlucose Oxidase, Glucose21decisions
  • NBWSystem, Test, Blood Glucose, Over The Counter13decisions
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)3decisions
  • GJSTest, Time, Prothrombin2decisions
  • MRZAccessories, Pump, Infusion1decision
  • JJQColorimeter, Photometer, Spectrophotometer For Clinical Use1decision

Also: LZG (1).

Whose devices does it build on?

Its devices cite 14 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 61 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K024194One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 200315cite it
  • K984261Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 19998cite it
  • K053529Onetouch Ultra 2 Blood Glucose Monitoring SystemLifescan, Inc. · 20066cite it
  • K984527IN Touch Diabetes Management SoftwareLifescan, Inc. · 19996cite it
  • K072543Onetouch Select Blood Glucose Monitoring SystemLifescan, Inc. · 20073cite it
  • K021819One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc. · 20023cite it

What has FDA decided for it lately?

  • K132618Onetouch RevealLifescan, Inc. · 2013
  • K120558Onetouch Reveal Diabetes Management ApplicationLifescan, Inc. · 2013
  • K093745One Touch Verio Blood Glucose Monitoring SystemLifescan, Inc. · 2011
  • K082590Symphony Meter RemoteLifescan, Inc. · 2008
  • K082513Onetouch Vita Blood Glucose Monitoring SystemLifescan, Inc. · 2008
  • K081318Onetouch Zoom Diabetes Management ProgramLifescan, Inc. · 2008
  • K073231Onetouch Ultralink Blood Glucose Monitoring SystemLifescan, Inc. · 2008
  • K072543Onetouch Select Blood Glucose Monitoring SystemLifescan, Inc. · 20071 recall

All 42 as Lifescan, Inc. →

What has been recalled?

24 recalls linked to its devices; the latest:

  • K062195ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443Mar 16, 2021Class II
  • K062195ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174Mar 16, 2021Class II
  • K062195LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808…Feb 25, 2013Class II
  • K072543LifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 02168902. Testing…Feb 25, 2013Class II
  • K022724OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood…Feb 24, 2010
  • K023194OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose…Feb 24, 2010

Other applicant names beginning “Lifescan”

FDA records each applicant name separately; these may or may not be the same firm.

Lifescan Europe 3Lifescan Europe, A Division of Cilag GmbH 1