Flexicare Neonatal Heated Wire Breathing System
FDA 510(k) K160540 · Flexicare Medical Limited.
510(k) numberK160540
Submission
- Device name
- Flexicare Neonatal Heated Wire Breathing System
- Applicant
- Flexicare Medical Limited.
Mountain Ash, GB - Received
- February 26, 2016
- Decision date
- June 23, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- BZE – Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5270
- Specialty
- Anesthesiology
Other 510(k)s with product code BZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252066 | inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit…BZE · Traditional | Vincent Healthcare Products Limited | 06/18/2026SE |
| K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant…BZE · Traditional | Medline Industries, LP | 03/25/2026SE |
| K243244 | Heated Breathing TubeBZE · Traditional | Guangdong Eda Technology Co., Ltd. | 07/25/2025SE |
| K241268 | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)BZE · Traditional | Exceleron Medical | 08/02/2024SE |
| K234032 | Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit…BZE · Traditional | Medline Industries, LP | 06/04/2024SE |
| K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)BZE · Traditional | Draegerwerk AG & CO Kgaa | 06/14/2023SE |
| K201418 | Sunset Heated CPAP TubeBZE · Traditional | Sunset Healthcare Solutions, Inc. | 01/29/2021SE |
| K173280 | Neonatal ConchaSmart Breathing CircuitsBZE · Traditional | Teleflexmedical, Inc. | 08/02/2018SE |
| K170378 | AirLife Adult Heated Wire BiPAP/NIV CircuitBZE · Traditional | Vyaire Medical | 09/14/2017SE |
| K153234 | AirLife Adult Heated Wire CircuitBZE · Traditional | Carefusion, Inc. | 07/07/2016SE |
More from Carefusion, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video…EOQ · Traditional | 09/02/2026SE |
| K251448 | FL-10000U Respiratory HumidifierBTT · Traditional | 01/16/2026SE |
| K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu…BTR · Traditional | 05/20/2025SE |
| K201666 | Single Use ManometerCAP · Traditional | 11/13/2020SE |
| K191909 | HepaShield Bacterial Viral Breathing System FilterCAH · Traditional | 03/23/2020SE |
| K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator…BTM · Traditional | 12/07/2018SE |
| K163300 | ThermoShield HME FilterCAH · Traditional | 03/22/2017SE |
| K161314 | Flexicare FL-9000U Respiratory Humidifier BaseBTT · Traditional | 07/06/2016SE |
| K150900 | Flexicare Heated Wire Breathing SystemsBZE · Traditional | 05/15/2015SE |
| K140473 | DualguardCCK · Traditional | 04/10/2014SE |
Questions and answers
When was Flexicare Neonatal Heated Wire Breathing System cleared by the FDA?
Flexicare Neonatal Heated Wire Breathing System (K160540) received a 510(k) decision of Substantially Equivalent on June 23, 2016, 118 days after the submission was received.
What is the product code of K160540?
The FDA product code is BZE – Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer, a Class II (moderate risk) device regulated under 21 CFR 868.5270.