Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CAO — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
323 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971348 | FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM | Green Field Medical Sourcing, Inc. | 1998-02-27 | 323 | 0 |
| K894032 | EVAC-TUBE | Sharn, Inc. | 1989-08-31 | 86 | 0 |
| K875226 | ESOPHAGEAL OBTURATOR/TRACHEAL TUBE | Sheridan Catheter Corp. | 1988-01-19 | 28 | 0 |
| K864200 | VETA/VENTED ESOPHAGEAL TUBE AIRWAY | Cranco Co. | 1987-03-17 | 141 | 0 |
| K863172 | RESPIRONICS PTL REVIVEEASY | Respironics, Inc. | 1986-11-04 | 78 | 0 |
| K761195 | ESOPHAGEAL OBTURATION AIRWAY | Mckesson Corp. | 1976-12-09 | 3 | 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