Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing— 510(k) K212779

Name: FDA 510(k) clearance K212779
Creator: U.S. Food and Drug Administration
Published: 2022-10-05

Substantially Equivalent

Coagusense, Inc.

FDA 510(k) clearance K212779 for Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing, Substantially Equivalent on 2022-10-05. Applicant: Coagusense, Inc.. Device class: 2.

Clearance details

Applicant: Coagusense, Inc.
Product code: Code GJS
Device class: Class 2
Regulation: 21 CFR 864.7750
Advisory panel: Hematology
Date received: 2021-09-01
Decision date: 2022-10-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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K243543 — microINR System2025-02-27
K230802 — Xprecia Prime Coagulation System2024-03-15
K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System2023-07-14

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Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.