Vyaire Medical, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under 2 spellings of the applicant name “Vyaire Medical, Inc.” (first 2017, latest 2024), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 219 days. Since 2017 the median was 219 days, against 236 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 219 |
| 2018 | 2 | 250 |
| 2019 | 3 | 136 |
| 2020 | 1 | 221 |
| 2021 | 2 | 338 |
| 2022 | 0 | — |
| 2023 | 1 | 90 |
| 2024 | 1 | 592 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vyaire Medical, Inc. took a median 219 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 236 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | 3 | 3 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 3 | 3 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 | 2 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 | 1 |
| CBK | Ventilator, Continuous, Facility Use | 1 | 1 |
Review panels
- Anesthesiology (8)
- Cardiovascular (3)
Most recent Vyaire Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230915 | AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask | CCK | 2024-11-12 | 592 |
| K231380 | AirLife DuoTherm Humidification System | BTT | 2023-08-10 | 90 |
| K201082 | LTV2 Series Ventilators | CBK | 2021-11-10 | 566 |
| K211294 | Multi-Link X2 ECG Cable and Leadwire System | DSA | 2021-08-16 | 110 |
| K200510 | Multi-LinkTM X2 ECG Adapter and Leadwires | DSA | 2020-10-09 | 221 |
| K191273 | Multi-Link X2 ECG and SpO2 Adapter | DSA | 2019-09-13 | 123 |
| K183567 | Vyntus/SentrySuite Product Line | BZC | 2019-08-23 | 245 |
| K190853 | Vyntus BODY | BZC | 2019-08-16 | 136 |
| K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART | BZC | 2018-11-30 | 172 |
| K171678 | Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable | CCK | 2018-04-30 | 328 |
1 earlier clearances. See the full list in Caduvo.
Recalls
63 product recalls in 13 recall events; 17 initiated in the last five years. Most recent: 2025-04-10.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Vyaire Medical, Inc. is the lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05383651: Post Market, Prospective Multicenter Observational Study of the Safety and Performance of Bellavista Ventilator (Completed, started 2023-02-01)
- NCT05175573: SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation (Completed, started 2022-06-07)
- NCT05229172: Fabian Prospective Assessment of Volume Guarantee (Fabian PaVoG) (Completed, started 2022-02-24)
- NCT04957472: Multicenter Study of the Safety and Performance of Fabian-PRICO for Saturation Targeting Routine Use in the NICU (Completed, started 2022-01-14)
- NCT04709627: enFlow IV Fluid and Blood Warming System (Completed, started 2021-07-06)
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Vyaire Medical, Inc. (9)
- Vyaire Medical (2)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vyaire Medical, Inc.?
FDA lists 11 510(k) clearances under 2 spellings of the applicant name “Vyaire Medical, Inc.” (first 2017, latest 2024), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vyaire Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vyaire Medical, Inc. is 219 days. Since 2017: 219 days, versus 236 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vyaire Medical, Inc.?
The most frequent FDA product codes under this applicant name are BZC (Calculator, Pulmonary Function Data, 3); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 3); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 2).
Next steps
- See all 11 Vyaire Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZC, Vyaire Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.