FDA product code HRC: Sterilizer, Soft-Lens, Thermal, Battery-Powered
HRC is the FDA product code for sterilizer, soft-lens, thermal, battery-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 HRC. The average 510(k) review took 65 days (median 65).
Classification
| Field | Value |
|---|---|
| Device name | Sterilizer, Soft-Lens, Thermal, Battery-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 HRC clearance
Top HRC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Osteo AG | 1 | 1992-03-11 |
Most recent HRC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920037 | Osteo AG | OSTEO COMPRESSION HIP SCREW | 1992-03-11 | 65 |
Recalls for HRC devices
openFDA lists no recalls for product code HRC.
Frequently asked questions
What is FDA product code HRC?
HRC is the FDA product code for sterilizer, soft-lens, thermal, battery-powered. It is a Class II device, regulated under 21 CFR 886.5928 and reviewed by the Ophthalmic panel.
What device class is HRC?
Class II, regulation 21 CFR 886.5928. Typical premarket route: 510(k).
How long does a 510(k) take for product code HRC?
Across 1 cleared submissions the average was 65 days from receipt to decision (median 65).
Which companies have the most HRC clearances?
Osteo AG (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HRC
- Run a recall and safety report across every HRC manufacturer
- Watch product code HRC 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 Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times