Breathing Circuit W/Heated Wire
FDA 510(k) K880769 · Dryden Corp.
510(k) numberK880769
Submission
- Device name
- Breathing Circuit W/Heated Wire
- Applicant
- Dryden Corp.
Indianapolis, IN, US - Received
- February 29, 1988
- Decision date
- August 24, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K880923 | Patient Ventilator IsolatorCBK · Traditional | 09/06/1988SE |
| K882285 | Nonrebreathing CircuitBTM · Traditional | 08/16/1988SE |
| K873928 | Universal TourniquetGAX · Traditional | 10/23/1987SE |
| K873927 | Reuseable Breathing TubesBZO · Traditional | 10/20/1987SE |
| K870859 | Bag-Tail Bleed ValveCAI · Traditional | 08/03/1987SE |
| K871386 | Breathing CircuitCAI · Traditional | 05/29/1987SE |
| K870858 | Badgwell Sampling CatheterCCK · Traditional | 05/14/1987SE |
| K861540 | Disposable Berman and Guedel AirwaysCAE · Traditional | 05/02/1986SE |
| K850644 | Nasopharyngeal Airway-RobertazziBTQ · Traditional | 03/21/1985SE |
| K842843 | Dryden Scavenger Interface System · Traditional | 07/27/1984SE |
Questions and answers
When was Breathing Circuit W/Heated Wire cleared by the FDA?
Breathing Circuit W/Heated Wire (K880769) received a 510(k) decision of Substantially Equivalent on August 24, 1988, 177 days after the submission was received.
What is the product code of K880769?
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.