Ventoux VC2; Ventoux VC3

Q: What is the product code of K223120?

The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.

FDA 510(k) K223120 · Flight Medical Innovations , Ltd.

Substantially Equivalent

510(k) numberK223120

Submission

Device name: Ventoux VC2; Ventoux VC3
Applicant: Flight Medical Innovations , Ltd.
Petach Tikva, IL
Received: October 3, 2022
Decision date: December 2, 2024
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

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
K241135	RESPOND(R) VentilatorCBK · Traditional	Corvent Medical, Inc.	11/13/2024SE

More from Corvent Medical, Inc.

510(k)	Device	Decision
K143035	Flight 60 VentilatorCBK · Traditional	03/30/2016SE
K130171	Flight 60 VentilatorCBK · Traditional	04/08/2014SE
K120726	Flight 60 VentilatorCBK · Traditional	07/06/2012SE
K111683	Flight 60 VentilatorCBK · Traditional	10/31/2011SE

Questions and answers

When was Ventoux VC2; Ventoux VC3 cleared by the FDA?

Ventoux VC2; Ventoux VC3 (K223120) received a 510(k) decision of Substantially Equivalent on December 2, 2024, 791 days after the submission was received.

What is the product code of K223120?

The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.