Ventrain

FDA 510(k) K132759 · Dolphys Medical B.V.

Substantially Equivalent

510(k) numberK132759

Submission

Device name
Ventrain
Applicant
Dolphys Medical B.V.
Eindhoven, NL
Received
September 4, 2013
Decision date
March 26, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTL – Ventilator, Emergency, Powered (Resuscitator)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5925
Specialty
Anesthesiology
Life-sustaining
Yes

Other 510(k)s with product code BTL

510(k)DeviceApplicantDecision
K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)BTL · Traditional Draegerwerk AG & CO Kgaa04/04/2025SE
K221634Oxymag - Transport and Emergency VentilatorBTL · Traditional Magnamed Tecnologia Medica S/A05/24/2023SE
K202219VORTRAN GO2VENT with PEEP ValveBTL · Traditional Vortran Medical Technology 1, Inc.02/11/2021SE
K193191MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagBTL · Traditional Weinmann Emergency Medical Technology GmbH + Co.…11/20/2020SE
K182956Puffin Lite Infant Resuscitation SystemBTL · Special International Biomedical01/18/2019SE
K173373SafeT T-Piece ResuscitatorBTL · Traditional Ventlab, LLC11/16/2018SE
K161420Moves SLCBTL · Traditional Thornhill Research, Inc.06/06/2017SE
K162968Vortran GO2VENTBTL · Traditional Vortran Medical Technology 1, Inc.04/10/2017SE
K141595O-Two E700,O-TWO E600,O-TWO E500BTL · Traditional O-Two Medical Technologies, Inc.03/16/2015SE
K142096T-Piece ResuscitatorBTL · Traditional Mercury Medical10/17/2014SE

Questions and answers

When was Ventrain cleared by the FDA?

Ventrain (K132759) received a 510(k) decision of Substantially Equivalent on March 26, 2014, 203 days after the submission was received.

What is the product code of K132759?

The FDA product code is BTL – Ventilator, Emergency, Powered (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5925.