FDA product code JPK: Mixture, Hematology Quality Control
JPK is the FDA product code for mixture, hematology quality control. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel. FDA has cleared 192 510(k) submissions under JPK, from 50 different applicants. The average 510(k) review took 72 days (median 45). FDA has posted 16 recalls for JPK devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Mixture, Hematology Quality Control |
| Device class | Class II |
| Regulation | 21 CFR 864.8625 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JPK clearance
Top JPK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| R&D Systems, Inc. | 45 | 2016-09-01 |
| Streck Laboratories, Inc. | 23 | 2004-10-19 |
| Streck | 12 | 2016-12-22 |
| Beckman Coulter, Inc. | 10 | 2010-12-21 |
| Coulter Electronics, Inc. | 8 | 1993-04-05 |
45 more applicants have JPK clearances. See the full list in Caduvo.
Most recent JPK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K160588 | Streck | XN CHECK BF | 2016-12-22 | 296 |
| K160590 | Streck | XN CHECK | 2016-12-22 | 296 |
| K160586 | Streck | XN-L CHECK | 2016-12-22 | 296 |
| K160606 | R&D Systems, Inc. | BC-5D Hematology Control | 2016-09-01 | 183 |
| K141964 | Streck | XN CHECK | 2014-12-05 | 140 |
Recalls for JPK devices
16 product recalls in 12 recall events; 3 initiated in the last five years and 0 still open. Most recent: 2022-11-07.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code JPK?
JPK is the FDA product code for mixture, hematology quality control. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel.
What device class is JPK?
Class II, regulation 21 CFR 864.8625. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JPK?
Across 192 cleared submissions the average was 72 days from receipt to decision (median 45).
Which companies have the most JPK clearances?
R&D Systems, Inc. (45); Streck Laboratories, Inc. (23); Streck (12); Beckman Coulter, Inc. (10); Coulter Electronics, Inc. (8).
Have JPK devices been recalled?
Yes: 16 product recalls across 12 recall events; the most recent began 2022-11-07.
Next steps
- Run an FDA pathway report with predicate devices for product code JPK
- Run a recall and safety report across every JPK manufacturer
- Watch product code JPK 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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