HQO
12 FDA 510(k) clearances · Product code
83 daysmedian time to decision
99 days90th percentile
12clearances measured
FDA profile
- Official device name
- Unit, Cautery, Thermal, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4115
- Medical specialty
- Ophthalmic
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2021: 56 · 2022: 53 · 2023: 48 · 2024: 66 · 2025: 102 · 2026: 76
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STARION UNIVERSAL POWER SUPPLY (K070871) | Starion Instruments | 2007-04-13 |
| STARION UNIVERSAL POWER SUPPLY (UPS) (K043155) | Starion Instruments | 2004-12-09 |
| THERMAL CAUTERY UNIT, MODEL 150 (K002341) | Geiger Medical Technologies, Inc. | 2000-10-23 |
| AC POWERED THERMAL CAUTERY UNIT (K000893) | Starion Instruments | 2000-06-14 |
| MENTOR GEMINI HEMOSTATIC ERASER (K971538) | Mentor Ophthalmics, Inc. | 1997-07-14 |
| D.O.R.C. MICRODIATHERMY SYSTEM (K962135) | Dutch Ophthalmic USA, Inc. | 1996-08-29 |
| BIPOLAR ELECTROSURGICAL PENCIL (K943031) | Boston Surgical Products, Inc. | 1994-09-23 |
| ADLER DISPOSABLE BIPOLAR CORD (K900913) | Adler Instrument Co. | 1990-04-04 |
| VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF (K874367) | Spembly Medical , Ltd. | 1988-01-04 |
| SITE-MALIS BIPOLAR COAGULATOR MODULE (K852075) | Valley Forge Scientific Corp. | 1985-08-20 |
| EFFNER-EYE CAUTERY WITH BATTERY HANDLE (K844775) | Mecron Medical Products, Inc. | 1985-08-12 |
| MICROSURG CAUTERY (K810017) | Medical Products Development, Inc. | 1981-01-05 |
Track HQO automatically
Every clearance here is in the API, with alerts when new ones post.