Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
FKR — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
70 daysmedian FDA review time
145 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140571 | NXSTAGE PUREFLOW SL | Nxstage Medical, Inc. | 2014-05-15 | 70 | 8 |
| K111174 | NXSTAGE PUREFLOW SL | Nxstage Medical, Inc. | 2011-09-19 | 145 | 9 |
| K080919 | NXSTAGE PUREFLOW SL | Nxstage Medical, Inc. | 2008-10-15 | 197 | 1 |
| K060296 | NXSTAGE DIALYSATE PREPARATION MODULE | Nxstage Medical, Inc. | 2006-03-31 | 53 | 0 |
| K043436 | NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 | Nxstage Medical, Inc. | 2005-03-17 | 94 | 0 |
| K850435 | SARTORIUS AQUASART SM 40035 - DIALYSATE SYS | Sartorius Filters, Inc. | 1985-06-04 | 120 | 0 |
| K850756 | AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS | Travenol Laboratories, S.A. | 1985-03-20 | 23 | 0 |
| K810605 | CHEMATIC BICARBONATE DIALYSATE SYSTEM | Trimedyne, Inc. | 1981-06-16 | 102 | 0 |
| K810127 | GAMBRO BICARBONATE MODULE, BCM-10 | Gambro, Inc. | 1981-02-25 | 37 | 0 |
| K802465 | BICARB-O-MATE HEMODIALYSIS SOD. BICARB. | Renal Systems, Inc. | 1980-11-12 | 34 | 0 |
| K800772 | MOD. DM-357 BICARBONATE RETROFIT KIT | Extracorporeal Medical Specialities, Inc. | 1980-05-14 | 37 | 0 |
| K781303 | BIO-PRO UNIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-10-02 | 67 | 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