FDA product code HQO: Unit, Cautery, Thermal, Ac-Powered
HQO is the FDA product code for unit, cautery, thermal, ac-powered. It is a Class II device, regulated under 21 CFR 886.4115 and reviewed by the Ophthalmic panel. FDA has cleared 12 510(k) submissions under HQO, from 10 different applicants. The average 510(k) review took 76 days (median 80).
Classification
| Field | Value |
|---|---|
| Device name | Unit, Cautery, Thermal, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.4115 |
| 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 HQO clearance
Top HQO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Starion Instruments | 3 | 2007-04-13 |
| Geiger Medical Technologies, Inc. | 1 | 2000-10-23 |
| Mentor Ophthalmics, Inc. | 1 | 1997-07-14 |
| Dutch Ophthalmic USA, Inc. | 1 | 1996-08-29 |
| Boston Surgical Products, Inc. | 1 | 1994-09-23 |
5 more applicants have HQO clearances. See the full list in Caduvo.
Most recent HQO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070871 | Starion Instruments | STARION UNIVERSAL POWER SUPPLY | 2007-04-13 | 15 |
| K043155 | Starion Instruments | STARION UNIVERSAL POWER SUPPLY (UPS) | 2004-12-09 | 24 |
| K002341 | Geiger Medical Technologies, Inc. | THERMAL CAUTERY UNIT, MODEL 150 | 2000-10-23 | 83 |
| K000893 | Starion Instruments | AC POWERED THERMAL CAUTERY UNIT | 2000-06-14 | 86 |
| K971538 | Mentor Ophthalmics, Inc. | MENTOR GEMINI HEMOSTATIC ERASER | 1997-07-14 | 77 |
Recalls for HQO devices
openFDA lists no recalls for product code HQO.
Frequently asked questions
What is FDA product code HQO?
HQO is the FDA product code for unit, cautery, thermal, ac-powered. It is a Class II device, regulated under 21 CFR 886.4115 and reviewed by the Ophthalmic panel.
What device class is HQO?
Class II, regulation 21 CFR 886.4115. Typical premarket route: 510(k).
How long does a 510(k) take for product code HQO?
Across 12 cleared submissions the average was 76 days from receipt to decision (median 80).
Which companies have the most HQO clearances?
Starion Instruments (3); Geiger Medical Technologies, Inc. (1); Mentor Ophthalmics, Inc. (1); Dutch Ophthalmic USA, Inc. (1); Boston Surgical Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HQO
- Run a recall and safety report across every HQO manufacturer
- Watch product code HQO 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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