Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Avco Medical Products — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
178 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K802924 | KONTRON PERCUTAEOUS DOUBLE-LUMEN | Avco Medical Products | 1981-03-11 | 113 | 0 |
| K790241 | INTRA-AORTIC BALLOON-PUMP | Avco Medical Products | 1979-02-23 | 22 | 0 |
| K781848 | PUMP, BALLOON MODEL 10 | Avco Medical Products | 1979-01-23 | 92 | 0 |
| K770937 | PUMP, BYPASS, PULSATILE, AVCO | Avco Medical Products | 1977-11-17 | 178 | 0 |
| K770821 | PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT | Avco Medical Products | 1977-05-06 | 2 | 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