FDA product code GKR: System, Hemoglobin, Automated
GKR is the FDA product code for system, hemoglobin, automated. It is a Class II device, regulated under 21 CFR 864.5620 and reviewed by the Hematology panel. FDA has cleared 39 510(k) submissions under GKR, from 28 different applicants. The average 510(k) review took 103 days (median 77). FDA has posted 8 recalls for GKR devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Hemoglobin, Automated |
| Device class | Class II |
| Regulation | 21 CFR 864.5620 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
510(k) clearances per year for GKR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 270 |
| 2018 | 2 | 172 |
| 2019 | 1 | 214 |
| 2020 | 2 | 78 |
Compare with all 510(k) review times · Search every GKR clearance
Top GKR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hemocue AB | 3 | 2020-08-04 |
| Ekf-Diagnostic GmbH | 3 | 2020-06-12 |
| Stanbio Laboratory | 3 | 2009-06-10 |
| Hemocue, Inc. | 3 | 2004-06-10 |
| Immunostics Inc., | 2 | 2018-11-16 |
23 more applicants have GKR clearances. See the full list in Caduvo.
Most recent GKR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201217 | Hemocue AB | HemoCue Hb 301 System | 2020-08-04 | 90 |
| K200909 | Ekf-Diagnostic GmbH | Hemo Control (optional Add Pack Hemo Control DM) | 2020-06-12 | 67 |
| K181751 | Hemocue AB | HemoCue Hb 801 System | 2019-02-01 | 214 |
| K182298 | Immunostics Inc., | hemochroma PLUS System | 2018-11-16 | 84 |
| K172173 | Ekf-Diagnostic GmbH | DiaSpect Tm, DiaSpect Tm Cuvettes | 2018-04-06 | 261 |
Recalls for GKR devices
8 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-07-16.
| Year | Recalls |
|---|---|
| 2018 | 5 |
Frequently asked questions
What is FDA product code GKR?
GKR is the FDA product code for system, hemoglobin, automated. It is a Class II device, regulated under 21 CFR 864.5620 and reviewed by the Hematology panel.
What device class is GKR?
Class II, regulation 21 CFR 864.5620. Typical premarket route: 510(k).
How long does a 510(k) take for product code GKR?
Across 39 cleared submissions the average was 103 days from receipt to decision (median 77).
Which companies have the most GKR clearances?
Hemocue AB (3); Ekf-Diagnostic GmbH (3); Stanbio Laboratory (3); Hemocue, Inc. (3); Immunostics Inc., (2).
Have GKR devices been recalled?
Yes: 8 product recalls across 5 recall events; the most recent began 2018-07-16.
Next steps
- Run an FDA pathway report with predicate devices for product code GKR
- Run a recall and safety report across every GKR manufacturer
- Watch product code GKR 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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