Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FLD — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
149 daysmedian FDA review time
401 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133807 | MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS | Gambro Renal Products, Inc. | 2014-03-26 | 100 | 0 |
| K113313 | MOLECULAR ADSORBENT RECIRCULATING(MARS) | Gambro Renal Products, Inc. | 2012-12-14 | 401 | 0 |
| K033262 | MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) | Gambro Renal Products | 2005-05-27 | 596 | 0 |
| K992196 | BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) | Hemocleanse, Inc. | 1999-09-10 | 72 | 0 |
| K984546 | BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT | Hemocleanse, Inc. | 1999-08-13 | 234 | 0 |
| K971015 | AHCS HEMOPERFUSION SYSTEM | American Health Care Systems, Inc. | 1997-10-22 | 216 | 0 |
| K953751 | BIOLOGIC-DT SYSTEM | Hemocleanse, Inc. | 1996-02-15 | 189 | 0 |
| K885017 | HEMOSORBA CH-500, CH-350 AND CH-180 | Asahi Medical Co., Ltd. | 1989-03-17 | 102 | 0 |
| K873643 | GAMBRO ADSORBA 150C | Gambro, Inc. | 1987-12-29 | 111 | 0 |
| K840532 | HEMOPERFUSION SYSTEM TP-400 | Extracorporeal Medical Specialities, Inc. | 1984-05-30 | 119 | 0 |
| K831029 | HEMOPERFUSION SYSTEM TP-400 | Extracorporeal Medical Specialities, Inc. | 1983-08-26 | 149 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda