JRL
9 FDA 510(k) clearances · Product code
27 daysmedian time to decision
119 days90th percentile
9clearances measured
FDA profile
- Official device name
- Unit, Filter, Membrane
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Medical specialty
- Clinical Chemistry
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1992: 1 · 1994: 1 · 1999: 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 |
|---|---|---|
| ACRO PACK (K822121) | Gelman Sciences, Inc. | 1982-08-05 |
| CENTRIFREE MICROPARTITION SYSTEM (K820455) | Amicon, Inc. | 1982-03-15 |
| EMIT FREELEVEL SYSTEM I (K820224) | Syva Co. | 1982-02-23 |
| IL 703, STAT SEPARATOR (K812750) | Instrumentation Laboratory CO | 1982-01-26 |
| VACUSHIELD TM (K813159) | Gelman Sciences, Inc. | 1981-12-08 |
| ACRODISC (K810829) | Gelman Sciences, Inc. | 1981-04-08 |
| ULTRAFREE CALCIUM FILTER (K801500) | Millipore Corp. | 1980-08-20 |
| ULTRA-FREE (K790445) | Millipore Corp. | 1979-06-28 |
| CEA-IMMERSIBLE SEPARATOR (K781043) | Millipore Corp. | 1978-09-15 |
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Every clearance here is in the API, with alerts when new ones post.