Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pioneer Viggo, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
33 daysmedian FDA review time
78 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K823120 | EXACTA & CONNECTA STOPCOCKS W/EXTENSION | Pioneer Viggo, Inc. | 1982-11-08 | 17 | 0 |
| K813454 | I.V. FILTER-PREVENT | Pioneer Viggo, Inc. | 1982-01-05 | 26 | 0 |
| K812159 | INTRAVASCULAR CATHETER | Pioneer Viggo, Inc. | 1981-08-31 | 33 | 0 |
| K811171 | VASCULON II I.V. CATHETER | Pioneer Viggo, Inc. | 1981-05-27 | 29 | 0 |
| K801537 | START IT WITH & WITHOUT I.V. CATH. UNIT | Pioneer Viggo, Inc. | 1980-09-19 | 78 | 0 |
| K791809 | BLOOD TRANSFUSION MICROFILTER | Pioneer Viggo, Inc. | 1979-10-26 | 39 | 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