FDA product code HRD: Sterilizer, Soft-Lens, Thermal, Ac-Powered
HRD is the FDA product code for sterilizer, soft-lens, thermal, ac-powered. It is a Class II device, regulated under 21 CFR 886.5928 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HRD. The average 510(k) review took 38 days (median 38). 4 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Sterilizer, Soft-Lens, Thermal, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.5928 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HRD clearance
Top HRD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Safeway Products, Inc. | 1 | 1982-10-29 |
Most recent HRD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822828 | Safeway Products, Inc. | SOFT LENS THERMAL DISINFECTING UNIT, A-C | 1982-10-29 | 38 |
Recalls for HRD devices
openFDA lists no recalls for product code HRD.
Frequently asked questions
What is FDA product code HRD?
HRD is the FDA product code for sterilizer, soft-lens, thermal, ac-powered. It is a Class II device, regulated under 21 CFR 886.5928 and reviewed by the Ophthalmic panel.
What device class is HRD?
Class II, regulation 21 CFR 886.5928. Typical premarket route: 510(k).
How long does a 510(k) take for product code HRD?
Across 1 cleared submissions the average was 38 days from receipt to decision (median 38).
Which companies have the most HRD clearances?
Safeway Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HRD
- Run a recall and safety report across every HRD manufacturer
- Watch product code HRD 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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