FDA product code JRR: Regulator, Temperature
JRR is the FDA product code for regulator, temperature. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under JRR, from 4 different applicants. The average 510(k) review took 22 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Regulator, Temperature |
| Device class | Class I |
| Regulation | 21 CFR 862.2050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every JRR clearance
Top JRR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Dade | 1 | 1982-08-05 |
| Therapac, Inc. | 1 | 1980-06-09 |
| Streck Laboratories, Inc. | 1 | 1978-06-06 |
| Gorman Rupp Industries | 1 | 1977-01-10 |
Most recent JRR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822132 | American Dade | DADE CHILL TRAY | 1982-08-05 | 16 |
| K801148 | Therapac, Inc. | HEMOGASTAT | 1980-06-09 | 27 |
| K780757 | Streck Laboratories, Inc. | KRYORACK/4 | 1978-06-06 | 29 |
| K761337 | Gorman Rupp Industries | AQUAMATIC K-MODULE MODEL K-10 | 1977-01-10 | 14 |
Recalls for JRR devices
openFDA lists no recalls for product code JRR.
Frequently asked questions
What is FDA product code JRR?
JRR is the FDA product code for regulator, temperature. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JRR?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JRR?
Across 4 cleared submissions the average was 22 days from receipt to decision (median 22).
Which companies have the most JRR clearances?
American Dade (1); Therapac, Inc. (1); Streck Laboratories, Inc. (1); Gorman Rupp Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JRR
- Run a recall and safety report across every JRR manufacturer
- Watch product code JRR 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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