Panels › Anesthesiology › Product code BZE · Class 2
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Regulation 868.5270
2510(k)s in 12 months (46 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in BZE
| Company | 510(k)s | Recalls |
|---|---|---|
| Carefusion 2200 Inc | 0 | 4 |
| Fisher & Paykel Healthcare, Ltd. | 3 | 0 |
| Vyaire Medical | 1 | 2 |
| Allegiance Healthcare Corp. | 2 | 0 |
| Applinc | 2 | 0 |
| Carefusion, Inc. | 2 | 0 |
| Flexicare Medical Limited. | 2 | 0 |
| Medline Industries, LP | 2 | 0 |
| Plastiflex Group NV | 2 | 0 |
| Respironics, Inc. | 2 | 0 |
| 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 |
| Jul 15, 2019 | Teleflex Medical Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column:
a) REF 870-07KIT
b) REF 870-09KIT
Product Usage:
The Neonatal ConchaSmart breathing cir Terminated |
BZE | K173280 |
| Sep 23, 2014 | Carefusion 2200 Inc CareFusion AirLife Heated Infant Breathing Circuit
Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. Terminated |
BZE | K915226 |
| Jun 29, 2012 | Carefusion 2200 Inc AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA Terminated |
BZE | K915226 |
| Jun 29, 2012 | Carefusion 2200 Inc AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico
Resp Terminated |
BZE | K915226 |
| Jun 29, 2012 | Carefusion 2200 Inc AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico
Respirat Terminated |
BZE | K915226 |
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