Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FIR — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
34 daysmedian FDA review time
85 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961137 | ATI PLASMA PUMP (PP-04) | Apheresis Technologies, Inc. | 1996-06-14 | 85 | 2 |
| K831953 | INFUSION PUMP | Cryosan, Inc. | 1983-07-19 | 34 | 0 |
| K830818 | ASAHI BLOOD/PLASMA PUMP #ABP-01A & | Parker Hannifin Corp. | 1983-04-12 | 28 | 0 |
| K821139 | SPS-SINGLE PATIENT SYSTEM | Extracorporeal Medical Specialities, Inc. | 1982-05-10 | 19 | 0 |
| K780410 | BLOOD PUMP-MODE S10K | 3M Health Care, Sarns | 1978-05-03 | 51 | 0 |
| K771705 | RS-7800 MINIPUMP | Renal Systems, Inc. | 1977-10-04 | 25 | 0 |
| K761050 | HEPARIN PUMP | Dws, Inc. | 1976-12-30 | 45 | 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