HMY
12 FDA 510(k) clearances · Product code
67 daysmedian time to decision
108 days90th percentile
12clearances measured
FDA profile
- Official device name
- Keratome, Battery-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4370
- Medical specialty
- Ophthalmic
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2001: 10 · 2002: 2 · 2003: 3 · 2020: 13
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 |
|---|---|---|
| ONEUSE- PLUS MICROKERATOME (K040297) | Moria SA | 2004-03-31 |
| BD K-4000 MICROKERATOME SYSTEM (K023092) | Becton, Dickinson & CO | 2002-10-18 |
| BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME (K022637) | Becton, Dickinson & CO | 2002-10-16 |
| M2 SINGLE USE MICROKERTOME (K022560) | Moria SA | 2002-09-27 |
| CARRIAZO BARRAQUER SINGLE USE MICROKERATOME (K003594) | Moria, Inc. | 2001-03-09 |
| CARRIAZO BARRAQUER II MICROKERATOME (K002191) | Moria, Inc. | 2000-10-12 |
| MILLENIUM MICROKERATOME, MODEL IMD-001 (K992687) | Industrial & Medical Design, Inc. | 1999-09-24 |
| KERATOME SYSTEM, MODEL K3000 (K984537) | Insight Technologies Instruments, LLC | 1999-05-14 |
| CARRIAZO BARRAQUER MICROKERATOME (K981741) | Moria, Inc. | 1998-07-24 |
| KERATOME SYSTEM (K974243) | Insight Technologies Instruments, LLC | 1998-01-20 |
| VISI-DRAPE OPHTHALMIC DRAPES (K902857) | Visitec Co. | 1990-07-31 |
| OSCILLATING KNIFE AND ACCESSORIES (K781412) | Codman & Shurtleff, Inc. | 1978-10-11 |
Track HMY automatically
Every clearance here is in the API, with alerts when new ones post.