HJB
5 FDA 510(k) clearances · Product code
96 daysmedian time to decision
195 days90th percentile
5clearances measured
FDA profile
- Official device name
- Instrument, Measuring, Corneal Radius
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1450
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1994: 1 · 1996: 5 · 2002: 3 · 2003: 1
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 |
|---|---|---|
| MARCO STANDARD KERATOMETERS (K930444) | Marco Ophthalmic, Inc. | 1993-08-09 |
| BURTON KERATOMETER - MODLE 2040 (K924779) | R.H. Burton Co. | 1993-04-05 |
| LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER (K864369) | Heidelberg Instruments | 1986-12-15 |
| KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER (K864037) | Kera Corp. | 1986-11-13 |
| ACUFEX COMPARATIVE SURGICAL KERATOMETER (K852424) | Acufex Microsurgical, Inc. | 1985-09-11 |
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Every clearance here is in the API, with alerts when new ones post.