FDA product code HQR: Apparatus, Cautery, Radiofrequency, Ac-Powered
HQR is the FDA product code for apparatus, cautery, radiofrequency, ac-powered. It is a Class II device, regulated under 21 CFR 886.4100 and reviewed by the Ophthalmic panel. FDA has cleared 11 510(k) submissions under HQR, from 11 different applicants. The average 510(k) review took 138 days (median 116).
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Cautery, Radiofrequency, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.4100 |
| 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 HQR clearance
Top HQR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Starion Instruments | 1 | 2005-02-25 |
| Ophthalmic Technologies, Inc. | 1 | 1999-04-04 |
| Refractec, Inc. | 1 | 1998-07-22 |
| C.M. Chance , Ltd. | 1 | 1998-03-13 |
| Storz | 1 | 1996-03-04 |
6 more applicants have HQR clearances. See the full list in Caduvo.
Most recent HQR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050308 | Starion Instruments | THERMAL CAUTERY PROBE | 2005-02-25 | 17 |
| K990064 | Ophthalmic Technologies, Inc. | DI-RHEX OPHTHALMIC DIATHERMY SYSTEM | 1999-04-04 | 86 |
| K980522 | Refractec, Inc. | REFRACTEC MCS-100 | 1998-07-22 | 162 |
| K972749 | C.M. Chance , Ltd. | PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S) | 1998-03-13 | 233 |
| K952151 | Storz | STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204) | 1996-03-04 | 301 |
Recalls for HQR devices
openFDA lists no recalls for product code HQR.
Frequently asked questions
What is FDA product code HQR?
HQR is the FDA product code for apparatus, cautery, radiofrequency, ac-powered. It is a Class II device, regulated under 21 CFR 886.4100 and reviewed by the Ophthalmic panel.
What device class is HQR?
Class II, regulation 21 CFR 886.4100. Typical premarket route: 510(k).
How long does a 510(k) take for product code HQR?
Across 11 cleared submissions the average was 138 days from receipt to decision (median 116).
Which companies have the most HQR clearances?
Starion Instruments (1); Ophthalmic Technologies, Inc. (1); Refractec, Inc. (1); C.M. Chance , Ltd. (1); Storz (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HQR
- Run a recall and safety report across every HQR manufacturer
- Watch product code HQR 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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