FLD
11 FDA 510(k) clearances · Product code
149 daysmedian time to decision
401 days90th percentile
11clearances measured
FDA profile
- Official device name
- Apparatus, Hemoperfusion, Sorbent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5870
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2002: 1 · 2017: 21
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 |
|---|---|---|
| MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT (K133807) | Gambro Renal Products, Inc. | 2014-03-26 |
| MOLECULAR ADSORBENT RECIRCULATING(MARS) (K113313) | Gambro Renal Products, Inc. | 2012-12-14 |
| MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) (K033262) | Gambro Renal Products | 2005-05-27 |
| BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) (K992196) | Hemocleanse, Inc. | 1999-09-10 |
| BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK (K984546) | Hemocleanse, Inc. | 1999-08-13 |
| AHCS HEMOPERFUSION SYSTEM (K971015) | American Health Care Systems, Inc. | 1997-10-22 |
| BIOLOGIC-DT SYSTEM (K953751) | Hemocleanse, Inc. | 1996-02-15 |
| HEMOSORBA CH-500, CH-350 AND CH-180 (K885017) | Asahi Medical Co., Ltd. | 1989-03-17 |
| GAMBRO ADSORBA 150C (K873643) | Gambro, Inc. | 1987-12-29 |
| HEMOPERFUSION SYSTEM TP-400 (K840532) | Extracorporeal Medical Specialities, Inc. | 1984-05-30 |
| HEMOPERFUSION SYSTEM TP-400 (K831029) | Extracorporeal Medical Specialities, Inc. | 1983-08-26 |
Track FLD automatically
Every clearance here is in the API, with alerts when new ones post.