HMP
17 FDA 510(k) clearances · Product code
55 daysmedian time to decision
91 days90th percentile
17clearances measured
FDA profile
- Official device name
- Pad, Eye
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4440
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1997: 2
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 |
|---|---|---|
| EYE PAD (K940333) | Certified Safety Mfg., Inc. | 1994-03-07 |
| STERILE,DISPOSABLE EYE DRESSING (K921349) | Deroyal Industries, Inc. | 1992-05-29 |
| EYE PAD (K904896) | Ulti-Med Intl., Inc. | 1990-12-05 |
| FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309 (K883822) | Consolidated Industries of Greater Syracuse, Inc. | 1988-11-22 |
| DONALDSON NATURAL EYEPATCH 'PATIENT PAK' (K874411) | Keeler Instruments, Inc. | 1988-01-27 |
| LIDSPLINT (K864810) | Precision Therapeutics, Inc. | 1987-01-20 |
| SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR (K861456) | Pantheon Products, Inc. | 1986-07-25 |
| DONALDSON NATURAL EYEPATCH (K860979) | Keeler Instruments, Inc. | 1986-04-04 |
| SURGICAL EYE PACK (K851906) | Xanmed Corp. | 1985-05-21 |
| VISOPROTECT: OCCULAR SHIELD (K850099) | Rockway Enterprises, Inc. | 1985-03-20 |
| VISOPROTECT OCCULAR SHIELD (K850005) | M.S.G. Health Systems, Inc. | 1985-03-20 |
| VISITEC EYE SHIELD (K843197) | Visitec Co. | 1984-10-05 |
| CONPHAR EYE PROTECTOR (K803145) | Conphar, Inc. | 1981-02-05 |
| EYE PADS (K802799) | Secol Co. | 1980-12-17 |
| EYE PADS CAT.#581-599 (K801995) | Pollak (Intl.), Ltd. | 1980-09-09 |
| MEDSPEC OPERATIVE OPTHALMIC KIT (K800404) | Medi-Spec | 1980-04-24 |
| ISO-CARE KIT (K781539) | Nice-Pak Products, Inc. | 1978-11-03 |
Track HMP automatically
Every clearance here is in the API, with alerts when new ones post.