UNI-VENT-731 Series Ventilators, Model 731EMV+
FDA 510(k) K091238 · Impact Instrumentation, Inc.
510(k) numberK091238
Submission
- Device name
- UNI-VENT-731 Series Ventilators, Model 731EMV+
- Applicant
- Impact Instrumentation, Inc.
West Caldwell, NJ, US - Received
- April 27, 2009
- Decision date
- August 13, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
Other 510(k)s with product code CBK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253647 | Evita (V800); Evita (V600)CBK · Traditional | Draegerwerk AG & CO Kgaa | 05/07/2026SE |
| K252663 | Inbentus VersatileCBK · Traditional | Iconic Solutions by Murcia, SL | 04/14/2026SE |
| K251888 | VPAP Pediatric Face MaskCBK · Traditional | Hsiner Co., Ltd. | 03/12/2026SE |
| K232365 | Vivo 45 LSCBK · Traditional | Oconnell Regulatory Consultants, Inc. | 12/19/2025SE |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A…CBK · Traditional | Fisher & Paykel Healthcare, Ltd. | 09/10/2025SE |
| 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 |
|---|---|---|
| K133196 | Impact Model 323 AspiratorJCX · Traditional | 03/10/2014SE |
| K111473 | Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorCBK · Traditional | 02/16/2012SE |
| K103318 | Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorCBK · Traditional | 04/07/2011SE |
| K071526 | Uni-Vent 731 Series Ventilators, Model 731, 731EMVCBK · Traditional | 12/10/2008SE |
| K051476 | Uni-Vent Model 73XBTL · Traditional | 10/28/2005SE |
| K032386 | Uni-Vent Model 730AEV (Automatic Emergency Ventilator)BTL · Traditional | 03/26/2004SE |
| K022062 | Impact, Universal Single-Limb, Ventilator Circuit, Model 820-0099-00MOD · Abbreviated | 05/06/2003SE |
| K951423 | Aspirator, Continuous & Programmable IntermittentBTA · Traditional | 04/18/1995SE |
| K941096 | Electric Vacum PumpBTA · Traditional | 01/05/1995SE |
| K931473 | Impact Model 753BTL · Traditional | 12/30/1994SE |
Questions and answers
When was UNI-VENT-731 Series Ventilators, Model 731EMV+ cleared by the FDA?
UNI-VENT-731 Series Ventilators, Model 731EMV+ (K091238) received a 510(k) decision of Substantially Equivalent on August 13, 2009, 108 days after the submission was received.
What is the product code of K091238?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.