Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FIL · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
57 daysmedian FDA review time
413 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011741 | CRIT-LINE MONITOR III TQA (CLM TQA) | Hemametrics | 2002-07-23 | 413 | 0 |
| K901038 | SPS 550-IPS (INTEGRATED PATIENT STATION) | Baxter Healthcare Corp | 1990-04-19 | 44 | 0 |
| K890329 | FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM | Fresenius USA, Inc. | 1989-05-11 | 108 | 0 |
| K790824 | REPGREEN ULTRAFILTRATION MONITOR | Cyberex Corp. | 1979-06-27 | 57 | 0 |
| K781633 | ULTRAFILTRATION SCALE | Extracorporeal Medical Specialities, Inc. | 1978-12-07 | 77 | 0 |
| K771875 | ULTRAFILTRATION MONITOR 5M9034 | Travenol Laboratories, S.A. | 1977-11-30 | 56 | 0 |
| K771227 | AK-10 | Gambro, Inc. | 1977-08-02 | 26 | 0 |
| K770137 | NEGATIVE PRESSURE ADAPTER 5M1350 | Travenol Laboratories, S.A. | 1977-02-01 | 8 | 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