JJH
15 FDA 510(k) clearances · Product code
77 daysmedian time to decision
257 days90th percentile
15clearances measured
FDA profile
- Official device name
- Clinical Sample Concentrator
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2310
- Medical specialty
- Clinical Chemistry
- Adverse events (MAUDE)
- 2015: 14 · 2018: 21 · 2020: 12 · 2021: 20 · 2022: 45 · 2025: 27
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 |
|---|---|---|
| ESENSOR RESPIRATORY VIRAL PANEL (K113731) | Clinical Micro Sensors, Inc. | 2012-09-10 |
| VIVASPIN 4 10,000 MW (K960298) | Vivascience, Inc. | 1996-03-19 |
| VIVAPORE 10 (K943965) | Vivascience, Inc. | 1995-04-11 |
| VIVAPORE 2 (K943966) | Vivascience, Inc. | 1995-04-11 |
| ULTRAFREE-CL (K941326) | Millipore Corp. | 1994-05-27 |
| NANOSEP N10 (K935496) | Intersep , Ltd. | 1994-04-26 |
| CENTRICON -50 CONCENTRATOR (K930168) | Amicon, Inc. | 1993-08-05 |
| CENTRICON CONCENTRATOR (K893733) | Amicon, Inc. | 1989-07-20 |
| CENTRICELL(TM) (K871290) | Polysciences, Inc. | 1987-08-05 |
| CENTRIPREP CONCENTRATOR (K870690) | Amicon, Inc. | 1987-03-19 |
| DUPONT PREP FOUR-SOLVENT RETROFIT KIT (K851393) | E.I. Dupont DE Nemours & Co., Inc. | 1985-07-12 |
| CENTRICON MICRO-CONCENTRATOR (K833919) | Amicon, Inc. | 1984-01-30 |
| MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG (K801772) | Radiation Technology, Inc. | 1980-08-20 |
| MINICON (K770398) | Amicon, Inc. | 1977-04-06 |
| MINICON CONCENTRATOR (K760592) | Amicon, Inc. | 1976-11-23 |
Track JJH automatically
Every clearance here is in the API, with alerts when new ones post.