Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dupaco, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
40 daysmedian FDA review time
119 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150518 | Airway with Bite Block and Tongue Depressor 80 mm, Airway wi | Dupaco, Inc. | 2015-06-29 | 119 | 0 |
| K841581 | UNIFILTER ANESTHESIA & RESPIRATORY FILT | Dupaco, Inc. | 1984-04-30 | 13 | 0 |
| K830395 | PEEPER | Dupaco, Inc. | 1983-03-11 | 32 | 0 |
| K821434 | EKG (ECG) ELECTRODES | Dupaco, Inc. | 1982-07-30 | 79 | 0 |
| K770084 | OPERATING ROOM VENTILATOR | Dupaco, Inc. | 1977-02-23 | 40 | 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