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Hemosense, Inc.

United StatesFDA applicant, unverified

Devices
3
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Hemosense, Inc. makes

Hemosense, Inc. makes medical devices such as the INRATIO 2 PT MONITORING SYSTEM, INRATIO SELF-TEST, and INRATIO, which are related to monitoring. These devices are specific types of products used for monitoring purposes.

The company's portfolio is regulated as Class II devices and is listed in the fda_510k registry. Hemosense, Inc. is based in the US.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

  • Inratio 2 Pt Monitoring System Ref K072727

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Inratio Self-Test Ref K021923

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Inratio Ref K020679

    Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 2 recalls initiated by Hemosense, Inc., the earliest on 2005-09-07 and the most recent on 2008-12-23. By recorded status: 2 terminated. The reasons filed fall into these groups: software or firmware and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2008

    • 23 Dec 2008 Z-1256-2009 Unclassified (pre-2012) Terminated INRatio Monitors that were manufactured with a specific EEPROM memory chip fail during use. The monitors report an error code and do not report a test result. Distribution: Worldwide Distribution in the US, Germany, Spain and Australia. Submission number: K072727

  • 2005

    • 7 Sep 2005 Z-0132-06 Unclassified (pre-2012) Terminated A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition. Distribution: Product was released for distribution to 20 consignees in US. The recall was appropriately extended to the consumer/user…
      Full distribution text Product was released for distribution to 20 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the users who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
      Submission numbers: K020679, K021923

Frequently asked questions

How many devices does Hemosense, Inc. have in the registry?

The registry currently lists 3 devices for Hemosense, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hemosense, Inc.'s devices?

Among its 3 most recently registered devices, Hemosense, Inc. has devices listed in FDA 510(k) (3 devices).

What risk classes do Hemosense, Inc.'s devices fall under?

Among its 3 most recently registered devices, the classes recorded for Hemosense, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Hemosense, Inc.?

FDA recall records list 2 recalls initiated by Hemosense, Inc., the most recent initiated on 23 Dec 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Hemosense, Inc. in the registry?

The most recently registered devices listed for Hemosense, Inc. include INRATIO 2 PT MONITORING SYSTEM, INRATIO SELF-TEST and INRATIO.

Generated automatically from registry data and not verified by a human reviewer.