Modification of Venturi Ventilator
FDA 510(k) K990429 · Cardiopulmonary Corp.
510(k) numberK990429
Submission
- Device name
- Modification of Venturi Ventilator
- Applicant
- Cardiopulmonary Corp.
Milford, CT, US - Received
- February 11, 1999
- Decision date
- February 24, 1999
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Special 510(k)
Device classification
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K251888 | VPAP Pediatric Face MaskCBK · Traditional | Hsiner Co., Ltd. | 03/12/2026SE |
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| K243767 | SV600, SV800 VentilatorCBK · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 08/28/2025SE |
| K251133 | AVEA disposable expiratory filter/water trap (11790)CBK · Traditional | Telesair, Inc. | 05/08/2025SE |
| K243394 | AF531 Oro-Nasal SE Face MaskCBK · Traditional | Respironics, Inc. | 12/30/2024SE |
| K233486 | 731 Series VentilatorCBK · Traditional | ZOLL Medical Corporation | 12/13/2024SE |
| K223120 | Ventoux VC2; Ventoux VC3CBK · Traditional | Flight Medical Innovations , Ltd. | 12/02/2024SE |
More from Flight Medical Innovations , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K130208 | Bernoulli Enterprise SoftwareMHX · Traditional | 12/20/2013SE |
| K091461 | Bernoulli Management System, Oxinet III and Lifegard VueMOD · Traditional | 08/14/2009SE |
| K061932 | Bernoulli Management System (MS) SoftwareMSX · Traditional | 09/14/2006SE |
| K051283 | Modification to Bernoulli Ventilator Management System SoftwareMSX · Special | 06/23/2005SE |
| K020018 | Modification to Bernoulli Ventilator Management System SoftwareMSX · Traditional | 02/21/2002SE |
| K011861 | Bernoulli Ventilator Management SystemMOD · Traditional | 11/06/2001SE |
| K982174 | Venturi VentilatorCBK · Traditional | 06/24/1998ST |
| K943412 | Venturi VentilatorCBK · Traditional | 10/16/1995ST |
Questions and answers
When was Modification of Venturi Ventilator cleared by the FDA?
Modification of Venturi Ventilator (K990429) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on February 24, 1999, 13 days after the submission was received.
What is the product code of K990429?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.