Company · US
Vyaire Medical
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2024. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
63recalls (0 in 12 months)
13recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OEV | Cardiopulmonary Resuscitation Aid Kit | 35 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 11 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 5 |
| CBK | Ventilator, Continuous, Facility Use | 5 |
| BZC | Calculator, Pulmonary Function Data | 4 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 3 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 3 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 |
| LGZ | Warmer, Thermal, Infusion Fluid | 2 |
| LSZ | Ventilator, High Frequency | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 |
| CBT | Arterial Blood Sampling Kit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 12, 2024 | K230915 | AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask Vyaire Medical, Inc. | CCK |
| Aug 10, 2023 | K231380 | AirLife DuoTherm Humidification System Vyaire Medical, Inc. | BTT |
| Nov 10, 2021 | K201082 | LTV2 Series Ventilators Vyaire Medical, Inc. | CBK |
| Aug 16, 2021 | K211294 | Multi-Link X2 ECG Cable and Leadwire System Vyaire Medical, Inc. | DSA |
| Oct 9, 2020 | K200510 | Multi-LinkTM X2 ECG Adapter and Leadwires Vyaire Medical, Inc. | DSA |
| Sep 13, 2019 | K191273 | Multi-Link X2 ECG and SpO2 Adapter Vyaire Medical, Inc. | DSA |
| Aug 23, 2019 | K183567 | Vyntus/SentrySuite Product Line Vyaire Medical, DE | BZC |
| Aug 16, 2019 | K190853 | Vyntus BODY Vyaire Medical, Inc. | BZC |
| Nov 30, 2018 | K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustabl Vyaire Medical, Inc., DE | BZC |
| Apr 30, 2018 | K171678 | Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, Vyaire Medical, Inc., FI | CCK |
| Sep 14, 2017 | K170378 | AirLife Adult Heated Wire BiPAP/NIV Circuit Vyaire Medical | BZE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2025 | Vyaire Medical Brand Name: AirLife
Product Name: AirLife Infant Heated Wire Circuit
Model/Catalog Number: AH265
Software Version: N/A
Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, Open, Classified |
BZE | K151303 |
| May 9, 2025 | Vyaire Medical Brand Name: AirLife
Product Name: AirLife Infant Heated Wire Circuit
Model/Catalog Number: AH165
Software Version: N/A
Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, hig Open, Classified |
BZE | K151303 |
| May 8, 2024 | Vyaire Medical, Inc. Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter fo Open, Classified |
BZC | K150810 |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004 Open, Classified |
BTM | None listed |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017 Open, Classified |
BTM | None listed |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2 Open, Classified |
BTM | None listed |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F Open, Classified |
BTM | None listed |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005 Open, Classified |
BTM | None listed |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2 Open, Classified |
BTM | None listed |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F Open, Classified |
BTM | None listed |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001 Open, Classified |
BTM | None listed |
| Feb 25, 2024 | Vyaire Medical AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000, Open, Classified |
BTM | None listed |
| Dec 5, 2023 | Vyaire Medical vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV) Completed |
LSZ | None listed |
| Dec 5, 2023 | Vyaire Medical vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV) Completed |
LSZ | None listed |
| Jun 15, 2023 | Vyaire Medical bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator Completed |
CBK | K183364 |
| Jun 15, 2023 | Vyaire Medical bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator Completed |
CBK | K183364 |
| Feb 16, 2022 | Vyaire Medical bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130.
The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adu Terminated |
CBK | K183364 |
| Nov 25, 2019 | Vyaire Medical bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air an Terminated |
CBK | K163127 |
| Jun 26, 2019 | Vyaire Medical enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions. Terminated |
LGZ | K060537 K130867 |
| Jun 26, 2019 | Vyaire Medical enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions. Terminated |
LGZ | K060537 K130867 |
| Aug 21, 2018 | Vyaire Medical The Tri-Flo Subglottic Suction System Terminated |
BSY | None listed |
| Aug 8, 2018 | Vyaire Medical AirLife Resuscitation Device, Pediatric labeled as the following:
a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018;
b. Pediatric, with mask, 40" oxygen r Terminated |
BTM | None listed |
| Aug 8, 2018 | Vyaire Medical AirLife Resuscitation Device, Adult labeled as the following:
a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004;
b. Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve, Terminated |
BTM | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are used to pr Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer, PEEP valve
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devic Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Replacement kit for outer shell, Broselow
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilati Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Broselow Hinkle Kit
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Broselow Hinkle Kit
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer, pressure-relief valve, PEEP valve
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are used to Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that a Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP valve
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positiv Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are used to provide posi Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP valve
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-relief valve
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are used to provide pos Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positi Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are used to provide pos Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief valve
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are used to provide po Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressure-relief valve
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are used to provide Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Adult, with mask, 28inch large bore tubing
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilat Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing, pressure-relief valve, CO2 detector, manometer
Product Usage:
The AirLife Resuscitation devices are manual resuscitation dev Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are us Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devic Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer
Product Usage:
The AirLife Resuscitation devices are manual resuscitation de Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are u Terminated |
OEV | None listed |
| May 10, 2018 | Vyaire Medical AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter
Product Usage:
The AirLife Resuscitation devices are manual resuscitation devices that are u Terminated |
OEV | None listed |
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