Bernoulli Management System, Oxinet III and Lifegard Vue
FDA 510(k) K091461 · Cardiopulmonary Corp.
510(k) numberK091461
Submission
- Device name
- Bernoulli Management System, Oxinet III and Lifegard Vue
- Applicant
- Cardiopulmonary Corp.
Milford, CT, US - Received
- May 18, 2009
- Decision date
- August 14, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MOD – Accessory To Continuous Ventilator (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
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| K242485 | EveryWareMOD · Traditional | Breas Medical AB | 05/20/2025SE |
| K161411 | Care Cycle Connect ApplicationMOD · Traditional | Respironics, Inc. | 02/17/2017SE |
| K052751 | Ventlink SystemMOD · Traditional | Mediserve Information Systems, Inc. | 12/23/2005SE |
| K052244 | Iisis, Version 1.0MOD · Traditional | Innovision Medical Technologies, LLC | 10/13/2005SE |
| K040712 | Air Safety Hepa, Model 3500MOD · Traditional | Air Safety, Ltd. | 06/03/2004SE |
| K022062 | Impact, Universal Single-Limb, Ventilator Circuit, Model 820-0099-00MOD · Abbreviated | Impact Instrumentation, Inc. | 05/06/2003SE |
| K010401 | Tri-Plex AdapterMOD · Traditional | The Medical Device Group, Inc. | 10/30/2002SE |
More from The Medical Device Group, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K130208 | Bernoulli Enterprise SoftwareMHX · Traditional | 12/20/2013SE |
| 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 |
| K990429 | Modification of Venturi VentilatorCBK · Special | 02/24/1999ST |
| K982174 | Venturi VentilatorCBK · Traditional | 06/24/1998ST |
| K943412 | Venturi VentilatorCBK · Traditional | 10/16/1995ST |
Questions and answers
When was Bernoulli Management System, Oxinet III and Lifegard Vue cleared by the FDA?
Bernoulli Management System, Oxinet III and Lifegard Vue (K091461) received a 510(k) decision of Substantially Equivalent on August 14, 2009, 88 days after the submission was received.
What is the product code of K091461?
The FDA product code is MOD – Accessory To Continuous Ventilator (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5895.