510(k) Report

FDA applicant

Coagusense, Inc.

Fremont, CA3 decisions2010–20221 recall

FDA records 3 decisions for Coagusense, Inc. (Fremont, CA) from 2010 to 2022: 3 510(k) clearances. All are in product code GJS (Test, Time, Prothrombin). Its devices cite 7 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

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 Coagusense, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2010: 12019: 12022: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2010high 1 (2022) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Coagusense, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Coagusense, 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

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K093243Coagusense Self-Test Prothrombin Time/Inr Monitoring SystemCoagusense, Inc. · 20101cites it
  • K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc. · 20191cites it

What has FDA decided for it lately?

  • K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingCoagusense, Inc. · 2022
  • K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc. · 20191 recall
  • K093243Coagusense Self-Test Prothrombin Time/Inr Monitoring SystemCoagusense, Inc. · 20101 recall

All 3 as Coagusense, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K093243a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test…May 25, 2022Class II