Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FIF · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
61 daysmedian FDA review time
97 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873279 | 8810 PUMP-PUMP SINGLE NEEDLE DEVICE | Cd Medical, Inc. | 1987-10-23 | 67 | 0 |
| K820173 | COBE SINGLE-NEEDLE CONTROLLER #18-756 | Cobe Laboratories, Inc. | 1982-03-23 | 61 | 0 |
| K802230 | BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP | Cardio Med Supplies, Inc. | 1980-12-22 | 97 | 0 |
| K801967 | MEDCOMP FEMORAL VEIN CATHETER | Medical Components, Inc. | 1980-09-26 | 38 | 0 |
| K792174 | MODEL DM 353 & DM-353-L SINGLE NEEDLE | Extracorporeal Medical Specialities, Inc. | 1979-11-16 | 18 | 0 |
| K772147 | GW 35 GUIDE WIRE | Sorensen Research | 1977-11-28 | 14 | 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