HMT
7 FDA 510(k) clearances · Product code
44 daysmedian time to decision
87 days90th percentile
7clearances measured
FDA profile
- Official device name
- Drape, Patient, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1998: 1 · 1999: 3 · 2002: 3 · 2008: 3
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 |
|---|---|---|
| VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE (K945738) | Visitec Co. | 1995-02-14 |
| STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY (K905460) | Angiosystems, Inc. | 1991-02-06 |
| SOLOS EYESITE DRAPES (K872620) | Solos Ophthalmology | 1987-07-31 |
| OPTHA PREP (K871706) | Treace Medical, Inc. | 1987-05-18 |
| SURGICAL DRAPES, OPHTHALMIN (K854613) | Charles Atkins & Co. | 1986-02-13 |
| DRAIN-R-DRAPE(EYE (K831340) | Sur-Tech, Inc. | 1983-06-08 |
| EYE DRAPE (K830822) | CooperVision, Inc. | 1983-04-06 |
Track HMT automatically
Every clearance here is in the API, with alerts when new ones post.