Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Venusa , Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
196 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K994429 | VENUSA, LTD. EXTENSION SET WITH FILTER | Venusa , Ltd. | 2000-03-03 | 64 | 0 |
| K981683 | HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01 | Venusa , Ltd. | 1998-07-28 | 76 | 0 |
| K905518 | BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET | Venusa , Ltd. | 1991-06-21 | 196 | 0 |
| K851975 | ENTERAL FEEDING BAG, 1000 ML, & TUBING SET | Venusa , Ltd. | 1985-09-05 | 121 | 0 |
| K843692 | FLU VEN I.V. SET 0153-C PERMA-SET | Venusa , Ltd. | 1984-10-31 | 42 | 0 |
| K842088 | FLU MET 2 | Venusa , Ltd. | 1984-08-17 | 85 | 0 |
| K812981 | FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) | Venusa , Ltd. | 1981-11-06 | 14 | 0 |
| K811914 | FLU VEN I.V. SETS | Venusa , Ltd. | 1981-08-03 | 33 | 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