510(k) Report

FDA applicant

Hemosense, Inc.

Milpitas, CA3 decisions2002–200710 recalls

FDA records 3 decisions for Hemosense, Inc. (Milpitas, CA) from 2002 to 2007: 3 510(k) clearances. All are in product code GJS (Test, Time, Prothrombin). Its devices cite 1 predicate, 1 of them its own earlier devices. 10 recalls are linked to its devices, 7 Class I.

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

FIG. A — Illustration, hematology panel, where it files most

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

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

4in 2016

2008: 12011: 12014: 3, 3 Class I2016: 4, 4 Class I
2007high 4 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • GJSTest, Time, Prothrombin3decisions

Who builds on its devices?

Later devices cite its devices 7 times; 1 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.

  • K072727Inratio 2 PT Monitoring SystemHemosense, Inc. · 20073cite it
  • K021923Inratio Self-TestHemosense, Inc. · 20022cite it
  • K020679InratioHemosense, Inc. · 20022cite it

What has FDA decided for it lately?

  • K072727Inratio 2 PT Monitoring SystemHemosense, Inc. · 20074 Class I recalls
  • K021923Inratio Self-TestHemosense, Inc. · 20022 Class I recalls
  • K020679InratioHemosense, Inc. · 20024 Class I recalls

All 3 as Hemosense, Inc. →

What has been recalled?

10 recalls linked to its devices; the latest:

  • K072727Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage…Jul 11, 2016Class I
  • K072727Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage…Jul 11, 2016Class I
  • K020679Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT…Jul 11, 2016Class I
  • K020679INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The…Jul 11, 2016Class I
  • K020679INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio…Dec 5, 2014Class I
  • K020679Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071…Dec 5, 2014Class I