FDA product code GKN: Timer, Clot, Automated
GKN is the FDA product code for timer, clot, automated. It is a Class II device, regulated under 21 CFR 864.5400 and reviewed by the Hematology panel. FDA has cleared 3 510(k) submissions under GKN, from 3 different applicants. The average 510(k) review took 211 days (median 232).
Classification
| Field | Value |
|---|---|
| Device name | Timer, Clot, Automated |
| Device class | Class II |
| Regulation | 21 CFR 864.5400 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GKN clearance
Top GKN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Vascular | 1 | 1995-10-31 |
| Medtronic Hemotec, Inc. | 1 | 1994-09-20 |
| Medical Innovations Corp. | 1 | 1992-06-16 |
Most recent GKN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K953870 | Medtronic Vascular | ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS | 1995-10-31 | 75 |
| K940426 | Medtronic Hemotec, Inc. | MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER | 1994-09-20 | 232 |
| K913320 | Medical Innovations Corp. | MIL CM-II COAGULATION MACHINE | 1992-06-16 | 327 |
Recalls for GKN devices
openFDA lists no recalls for product code GKN.
Frequently asked questions
What is FDA product code GKN?
GKN is the FDA product code for timer, clot, automated. It is a Class II device, regulated under 21 CFR 864.5400 and reviewed by the Hematology panel.
What device class is GKN?
Class II, regulation 21 CFR 864.5400. Typical premarket route: 510(k).
How long does a 510(k) take for product code GKN?
Across 3 cleared submissions the average was 211 days from receipt to decision (median 232).
Which companies have the most GKN clearances?
Medtronic Vascular (1); Medtronic Hemotec, Inc. (1); Medical Innovations Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GKN
- Run a recall and safety report across every GKN manufacturer
- Watch product code GKN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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