FDA product code JZR: Support Gels
JZR is the FDA product code for support gels. It is a Class I device, regulated under 21 CFR 866.4900 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under JZR, from 2 different applicants. The average 510(k) review took 233 days (median 233).
Classification
| Field | Value |
|---|---|
| Device name | Support Gels |
| Device class | Class I |
| Regulation | 21 CFR 866.4900 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JZR clearance
Top JZR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fmc Corp. | 1 | 1995-02-24 |
| Helena Laboratories | 1 | 1983-07-07 |
Most recent JZR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K940037 | Fmc Corp. | I.D. AND SEAKEM GTG AGAROSES | 1995-02-24 | 416 |
| K831603 | Helena Laboratories | TITAN GE/IEPLATE | 1983-07-07 | 50 |
Recalls for JZR devices
openFDA lists no recalls for product code JZR.
Frequently asked questions
What is FDA product code JZR?
JZR is the FDA product code for support gels. It is a Class I device, regulated under 21 CFR 866.4900 and reviewed by the Immunology panel.
What device class is JZR?
Class I, regulation 21 CFR 866.4900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JZR?
Across 2 cleared submissions the average was 233 days from receipt to decision (median 233).
Which companies have the most JZR clearances?
Fmc Corp. (1); Helena Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JZR
- Run a recall and safety report across every JZR manufacturer
- Watch product code JZR 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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