# Vyaire Medical, Inc.

- Location (FDA's records): Mettawa, IL
- FDA decisions: 11 (2017–2024): 11 510(k) clearances
- Names in FDA's records: Vyaire Medical, Inc. (9); Vyaire Medical (2)
- Product codes: DSA (3), BZC (3), CCK (2), BTT (1), BZE (1), CBK (1)
- 510(k) review time since 2016: median 221 days, against 258 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 12 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Carefusion Germany 234 GmbH: 3 (https://510kreport.com/company/carefusion-germany-234)
- Fisher & Paykel Healthcare, Ltd.: 2 (https://510kreport.com/company/fisher-paykel-healthcare)
- Carefusion 2200, Inc.: 2 (https://510kreport.com/company/carefusion-2200)
- Carefusion 303, Inc.: 1 (https://510kreport.com/company/carefusion-303)
- Catheter Research, Inc.: 1 (https://510kreport.com/company/catheter-research)
- Pulmonetic Systems, Inc.: 1 (https://510kreport.com/company/pulmonetic-systems)
- Care Fusion: 1 (https://510kreport.com/company/care-fusion)

## Firms that cite its devices most
- Meditera Tibbi Malzeme San VE Tic AS: 1 (https://510kreport.com/company/meditera-tibbi-malzeme-san-ve-tic)
- Stryker Physio-Control: 1 (https://510kreport.com/company/stryker-physio-control)

## Its most-cited devices
- 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 (2018), cited by 1
- K211294: Multi-Link X2 ECG Cable and Leadwire System (2021), cited by 1
- K181524: Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART (2018), cited by 1

## Recent decisions
- K230915: AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask (Nov 12, 2024)
- K231380: AirLife DuoTherm™ Humidification System (Aug 10, 2023)
- K201082: LTV2 Series Ventilators (Nov 10, 2021)
- K211294: Multi-Link X2 ECG Cable and Leadwire System (Aug 16, 2021)
- K200510: Multi-LinkTM X2 ECG Adapter and Leadwires (Oct 9, 2020)
- K191273: Multi-Link X2 ECG and SpO2 Adapter (Sep 13, 2019)
- K183567: Vyntus/SentrySuite Product Line (Aug 23, 2019)
- K190853: Vyntus BODY (Aug 16, 2019)

Source page: https://510kreport.com/company/vyaire-medical