FDA product code JRG: Block, Heating
JRG is the FDA product code for block, heating. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under JRG, from 3 different applicants. The average 510(k) review took 48 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Block, Heating |
| 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 JRG clearance
Top JRG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boekel Industries, Inc. | 1 | 1983-02-18 |
| Armkel, LLC | 1 | 1979-05-03 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1978-10-03 |
Most recent JRG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823766 | Boekel Industries, Inc. | BLOOD GAS INCUBATOR #260650 | 1983-02-18 | 66 |
| K790549 | Armkel, LLC | HEATING BLOCK, WAMPOLE 37 C | 1979-05-03 | 44 |
| K781501 | Bd Becton Dickinson Vacutainer Systems Preanalytic | ENZAC INCUBATOR | 1978-10-03 | 34 |
Recalls for JRG devices
openFDA lists no recalls for product code JRG.
Frequently asked questions
What is FDA product code JRG?
JRG is the FDA product code for block, heating. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JRG?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JRG?
Across 3 cleared submissions the average was 48 days from receipt to decision (median 44).
Which companies have the most JRG clearances?
Boekel Industries, Inc. (1); Armkel, LLC (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JRG
- Run a recall and safety report across every JRG manufacturer
- Watch product code JRG 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 Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times