Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NWA — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
99 daysmedian FDA review time
390 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261541 | VisionAir Enhanced Stock Stent | VisionAir Solutions | 2026-06-01 | 24 | 0 |
| K243126 | TRACHEOBRONXANE™ DUMON® | Novatech SA | 2024-10-29 | 29 | 0 |
| K213969 | VisionAir Patient-Specific Airway Stent | New Cos Inc. Dba Visionair Solutions | 2022-10-07 | 291 | 0 |
| K182743 | Patient-Specific Airway Stent | New Cos, Inc. | 2019-10-23 | 390 | 0 |
| K971509 | ENDOXANE | Novatech SA | 1997-08-21 | 118 | 0 |
| K894380 | DUMON TRACHEOBRONCHIAL STENT | Bryan Corp. | 1989-10-24 | 99 | 0 |
| K873742 | HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES | Hood Laboratories | 1987-10-01 | 15 | 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