510(k) Report

510(k) · Cleared

Cleared

Heparin Assay Cartridges and Controls

K944115510(k) TraditionalCleared Mar 24, 1995213-day reviewClass II21 CFR 864.7525

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Hemotec, Inc. · GFT Protamine Sulphate

Cleared on Mar 24, 1995 after a 213-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 24, 1995
Review
213 days
Class
Class II
Product code
GFT
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K944115Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GFT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GFT devices

GFT Protamine Sulphate: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GFT

FDA has decided no GFT device since 2007.

Median 510(k) review, days · GFT

Too few GFT 510(k)s in any year since 2007 to give a median.

Recalls per year · GFT

No recall names GFT since 2007.

Adverse event reports per year · GFT

No MAUDE report names GFT since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Medtronic Hemotec, Inc.

5 FDA decisions under this applicant name. See the company

  • K954202Platelet Function Test Assay Cartridges for the Hepcon HMSMedtronic Hemotec, Inc. · 1996
  • K940426Medtronic Hemotec Act II Automated Coagulation TimerMedtronic Hemotec, Inc. · 1994
  • K923594Clottrac Coagulation ControlMedtronic Hemotec, Inc. · 1992
  • K922031HMS Purple and Black Heparin Cartridges & ControlMedtronic Hemotec, Inc. · 1992

Recent decisions in GFT

The GFT category page

  • K910105Protamine Response Test Catalogue Number PRT 200International Technidyne Corp. · 1991

https://510kreport.com/device/K944115 · printed Nov 4, 2026

Cite this page

510(k) Report. “K944115: Heparin Assay Cartridges and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944115

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026