Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Unicor, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
36 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953786 | UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS | Unicor, Inc. | 1995-09-19 | 36 | 0 |
| K953788 | UNICOR, INC. GAS SAMPLING LINES & CONNECTORS | Unicor, Inc. | 1995-09-19 | 36 | 0 |
| K953787 | UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT | Unicor, Inc. | 1995-09-19 | 36 | 0 |
| K953784 | UNICOR, INC. CORRUGATED TUBING | Unicor, Inc. | 1995-09-19 | 36 | 0 |
| K953785 | UNICOR, INC. VENTILATOR HOSES | Unicor, Inc. | 1995-09-18 | 35 | 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