510(k) Report

510(k) · Cleared

Cleared

Medtronic Hemotec Act II Automated Coagulation Timer

K940426510(k) TraditionalCleared Sep 20, 1994232-day reviewClass II21 CFR 864.5400

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

Medtronic Hemotec, Inc. · GKN Timer, Clot, Automated

Cleared on Sep 20, 1994 after a 232-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 20, 1994
Review
232 days
Class
Class II
Product code
GKN
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K940426Source: 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 GKN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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 GKN devices

GKN Timer, Clot, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKN

FDA has decided no GKN device since 2007.

Median 510(k) review, days · GKN

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

Recalls per year · GKN

No recall names GKN since 2007.

Adverse event reports per year · GKN

51in 2025

2015: 32017: 22019: 12020: 12021: 122022: 542023: 1202024: 542025: 51
2007high 120 (2023) · low 0 (2007)2025

MAUDE reports naming product code GKN, not matched to any one device; reports are not rates.

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—03
20160—00
20170—02
20180—00
20190—01
20200—01
20210—012
20220—054
20230—0120
20240—054
20250—051
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
  • K944115Heparin Assay Cartridges and ControlsMedtronic Hemotec, Inc. · 1995
  • K923594Clottrac Coagulation ControlMedtronic Hemotec, Inc. · 1992
  • K922031HMS Purple and Black Heparin Cartridges & ControlMedtronic Hemotec, Inc. · 1992

Recent decisions in GKN

The GKN category page

  • K953870Acttrac Electronic Control Device for the Act & Act II Coagulation InstrumentsMedtronic Vascular · 1995
  • K913320Mil CM-II Coagulation MachineMedical Innovations Corp. · 1992

https://510kreport.com/device/K940426 · printed Nov 4, 2026

Cite this page

510(k) Report. “K940426: Medtronic Hemotec Act II Automated Coagulation Timer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940426

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