FDA product code GKP: Instrument, Coagulation, Automated
GKP is the FDA product code for instrument, coagulation, automated. It is a Class II device, regulated under 21 CFR 864.5400 and reviewed by the Hematology panel. FDA has cleared 49 510(k) submissions under GKP, 2 in the last five years, from 18 different applicants. The average 510(k) review took 108 days (median 71); 28 days on average over the last three years. FDA has posted 31 recalls for GKP devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Coagulation, 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 |
510(k) clearances per year for GKP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 71 |
| 2024 | 1 | 28 |
Compare with all 510(k) review times · Search every GKP clearance
Top GKP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dade Behring, Inc. | 9 | 2003-09-08 |
| Instrumentation Laboratory CO | 8 | 2016-03-03 |
| Medical Laboratory Automation Systems, Inc. | 5 | 1996-09-10 |
| Helena Laboratories | 5 | 1993-08-23 |
| Organon Teknika Corp. | 3 | 1999-06-01 |
13 more applicants have GKP clearances. See the full list in Caduvo.
Most recent GKP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242127 | Instrumentation Laboratory (IL) Co. | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) | 2024-08-16 | 28 |
| K231031 | Instrumentation Laboratory Company | ACL TOP Family 70 Series | 2023-06-21 | 71 |
| K160276 | Instrumentation Laboratory CO | ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) | 2016-03-03 | 30 |
| K150877 | Instrumentation Laboratory CO | ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS | 2015-12-13 | 256 |
| K091980 | Instrumentation Laboratory CO | ACL TOP 700 LAS | 2009-09-22 | 83 |
Recalls for GKP devices
31 product recalls in 11 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-07-13.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code GKP?
GKP is the FDA product code for instrument, coagulation, automated. It is a Class II device, regulated under 21 CFR 864.5400 and reviewed by the Hematology panel.
What device class is GKP?
Class II, regulation 21 CFR 864.5400. Typical premarket route: 510(k).
How long does a 510(k) take for product code GKP?
Across 49 cleared submissions the average was 108 days from receipt to decision (median 71).
Which companies have the most GKP clearances?
Dade Behring, Inc. (9); Instrumentation Laboratory CO (8); Medical Laboratory Automation Systems, Inc. (5); Helena Laboratories (5); Organon Teknika Corp. (3).
Have GKP devices been recalled?
Yes: 31 product recalls across 11 recall events; the most recent began 2023-07-13.
Next steps
- Run an FDA pathway report with predicate devices for product code GKP
- Run a recall and safety report across every GKP manufacturer
- Watch product code GKP 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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