HOE
7 FDA 510(k) clearances · Product code
35 daysmedian time to decision
97 days90th percentile
7clearances measured
FDA profile
- Official device name
- Caliper, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Medical specialty
- Ophthalmic
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| KOI(TM) BLADE GAUGE, MODEL KOI-132 (K881094) | CooperVision, Inc. | 1988-04-01 |
| CALIPER-OPTHALMIC (K813315) | Design Research Assoc., Inc. | 1982-03-01 |
| KREMER BLADE GAUGE (K820050) | Accutome, Inc. | 1982-02-24 |
| BLADE GAUGE (K812011) | Koi, Inc. | 1981-07-28 |
| BLEPHAROMETER (K801937) | Aztec Medical Products, Inc. | 1980-09-16 |
| KELMAN DIPSTICK (K792383) | V. Mueller O.V. Baxter Healthcare Corp. | 1979-12-11 |
| RULER, WECK SCOTT (K781715) | Edward Weck, Inc. | 1978-12-04 |
Track HOE automatically
Every clearance here is in the API, with alerts when new ones post.