FDA product code GKB: Device, Automated Sedimentation Rate
GKB is the FDA product code for device, automated sedimentation rate. It is a Class I device, regulated under 21 CFR 864.5800 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under GKB. The average 510(k) review took 26 days (median 26). FDA has posted 3 recalls for GKB devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Automated Sedimentation Rate |
| Device class | Class I |
| Regulation | 21 CFR 864.5800 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GKB clearance
Top GKB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gespac, Inc. | 2 | 1989-05-24 |
Most recent GKB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K892522 | Gespac, Inc. | SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED | 1989-05-24 | 43 |
| K890503 | Gespac, Inc. | SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE | 1989-02-10 | 9 |
Recalls for GKB devices
3 product recalls in 2 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2023-04-14.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code GKB?
GKB is the FDA product code for device, automated sedimentation rate. It is a Class I device, regulated under 21 CFR 864.5800 and reviewed by the Hematology panel.
What device class is GKB?
Class I, regulation 21 CFR 864.5800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GKB?
Across 2 cleared submissions the average was 26 days from receipt to decision (median 26).
Which companies have the most GKB clearances?
Gespac, Inc. (2).
Have GKB devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2023-04-14.
Next steps
- Run an FDA pathway report with predicate devices for product code GKB
- Run a recall and safety report across every GKB manufacturer
- Watch product code GKB 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.
All Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times