Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DQI · Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
146 daysmedian FDA review time
266 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960486 | KSEA MODEL 383320 20 ANGIOMAT | Karl Storz Endoscopy | 1996-10-25 | 266 | 0 |
| K935763 | SURGIPUMP | W.O.M. World of Medicine GmbH | 1994-04-21 | 146 | 0 |
| K922541 | USCI SUPER 9 PTCA GUIDING CATHETER | C.R. Bard, Inc. | 1992-12-08 | 193 | 0 |
| K924110 | LEOCOR CORFLO PUMP -- MODIFICATION | Leocor, Inc. | 1992-09-01 | 90 | 0 |
| K905189 | BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL) | Baxter Healthcare Corp | 1991-01-30 | 72 | 0 |
| K902444 | CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP | Intramed Laboratories, Inc. | 1990-08-30 | 90 | 0 |
| K895688 | NOBLES-LAI ENGINEERING INFUSION PUMP | Nobles-Lai Engineering, Inc. | 1990-02-26 | 157 | 0 |
| K895074 | ANGIOSCOPY PUMP | Baxter Healthcare Corp | 1990-01-31 | 170 | 0 |
| K871422 | OLYMPUS ANGIOSCOPY PUMP | Olympus Corp. | 1987-08-12 | 125 | 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