Heated Wire Circuits for SCT 3000 Heated Humidifier
FDA 510(k) K962220 · Marquest Medical Products, Inc.
510(k) numberK962220
Submission
- Device name
- Heated Wire Circuits for SCT 3000 Heated Humidifier
- Applicant
- Marquest Medical Products, Inc.
Englewood, CO, US - Received
- June 10, 1996
- Decision date
- January 14, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K050066 | C-CO2 Colorimetric CO2 IndicatorCCK · Traditional | 03/01/2005SE |
| K970478 | SCT 3000 Heated HumidifierBTT · Traditional | 07/16/1997SE |
| K962223 | Water Chambers for ST 3000 Heated HumidifierBTT · Traditional | 01/14/1997SE |
| K961838 | Respirgard II, SpirogardCAH · Traditional | 10/18/1996SE |
| K960972 | Disposable Gas Sampling Interface KitsCCK · Traditional | 10/18/1996SE |
| K904690 | Temp Marq(Tm) Convective Warming SystemDWJ · Traditional | 02/01/1991SE |
| K903138 | Marquest SCT 3000, Heated Humidification SystemBTT · Traditional | 10/11/1990SE |
| K902632 | Gas-Lyte 1CC and 3CC Arterial Blood SamplersCBT · Traditional | 09/04/1990SE |
| K903307 | Temp Marq Temperature Trend IndicatorKPD · Traditional | 08/17/1990SE |
| K880979 | Marquest SCT 2000, Heated Humidification SystemBTT · Traditional | 07/15/1988SE |
Questions and answers
When was Heated Wire Circuits for SCT 3000 Heated Humidifier cleared by the FDA?
Heated Wire Circuits for SCT 3000 Heated Humidifier (K962220) received a 510(k) decision of Substantially Equivalent on January 14, 1997, 218 days after the submission was received.
What is the product code of K962220?
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.