Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vyaire Medical, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
172 daysmedian FDA review time
592 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230915 | AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask | Vyaire Medical, Inc. | 2024-11-12 | 592 | 0 |
| K231380 | AirLife DuoTherm™ Humidification System | Vyaire Medical, Inc. | 2023-08-10 | 90 | 0 |
| K201082 | LTV2 Series Ventilators | Vyaire Medical, Inc. | 2021-11-10 | 566 | 0 |
| K211294 | Multi-Link X2 ECG Cable and Leadwire System | Vyaire Medical, Inc. | 2021-08-16 | 110 | 0 |
| K200510 | Multi-LinkTM X2 ECG Adapter and Leadwires | Vyaire Medical, Inc. | 2020-10-09 | 221 | 0 |
| K191273 | Multi-Link X2 ECG and SpO2 Adapter | Vyaire Medical, Inc. | 2019-09-13 | 123 | 0 |
| K190853 | Vyntus BODY | Vyaire Medical, Inc. | 2019-08-16 | 136 | 0 |
| K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus | Vyaire Medical, Inc. | 2018-11-30 | 172 | 0 |
| K171678 | Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 1 | Vyaire Medical, Inc. | 2018-04-30 | 328 | 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