Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Airway Management, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
191 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181482 | myTAP2 | Airway Management, Inc. | 2018-08-31 | 87 | 0 |
| K160239 | TAP 3, TAP 1 | Airway Management, Inc. | 2016-08-10 | 191 | 0 |
| K122350 | TAP PAP NASAL PILLOW MASK | Airway Management, Inc. | 2012-11-01 | 90 | 0 |
| K062951 | TAP III ANTI-SNORING DEVICE | Airway Management, Inc. | 2006-12-12 | 74 | 0 |
| K061732 | TAP-T | Airway Management, Inc. | 2006-07-12 | 22 | 0 |
| K060388 | TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIAN | Airway Management, Inc. | 2006-05-17 | 92 | 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