FHS
12 FDA 510(k) clearances · Product code
58 daysmedian time to decision
106 days90th percentile
12clearances measured
FDA profile
- Official device name
- Dialyzer, Single Coil
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MICROCOIL 80 DIALYZER (K812811) | Erika, Inc. | 1981-12-03 |
| MICROCOIL 150 DIALYZER (K811974) | Erika, Inc. | 1981-09-16 |
| THE VITA 2 DISPOSABLE DIALYZER (K801634) | Bellco Artifidial Organ Spec., Inc. | 1980-12-17 |
| MICRO-COIL 100 COIL DIALYZER (K800723) | Erika, Inc. | 1980-05-14 |
| GAMBRO LUNDIA COIL DIALYZER (K800174) | Gambro, Inc. | 1980-02-13 |
| DIALYZER, CD-800 COIL (K790223) | Travenol Laboratories, S.A. | 1979-03-26 |
| DIALYZER, DISP., COIL, LUNDIA (K781102) | Gambro, Inc. | 1978-10-17 |
| MODIFICATION TO KIDNEY DIALYZER (K771349) | Erika, Inc. | 1977-08-02 |
| DIALYZER, COIL, CD, LSA, 5M1765 (K770735) | Travenol Laboratories, S.A. | 1977-05-10 |
| COIL DIALYZER MODEL ALT 140 (K761358) | Bentley Laboratories, Inc. | 1977-01-10 |
| ERI-FLO 900 DIALYZER (K760702) | Erika, Inc. | 1976-11-19 |
| DIALYZER (MODEL 1850) (K760374) | Erika, Inc. | 1976-10-27 |
Track FHS automatically
Every clearance here is in the API, with alerts when new ones post.