Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model Vriresnus

FDA 510(k) K051322 · Smiths Medical International , Ltd.

Substantially Equivalent

510(k) numberK051322

Submission

Device name
Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model Vriresnus
Applicant
Smiths Medical International , Ltd.
Waukesha, WI, US
Received
May 20, 2005
Decision date
August 5, 2005
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

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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

More from Mercury Medical

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K123957Pneupac Parapac PlusBTL · Traditional 09/16/2013SE
K071527Pneupac VR1 Air MixBTL · Traditional 10/04/2007SE
K060945Portex Percutaneous Tracheostomy KitBTO · Traditional 06/19/2006SE

Questions and answers

When was Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model Vriresnus cleared by the FDA?

Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model Vriresnus (K051322) received a 510(k) decision of Substantially Equivalent on August 5, 2005, 77 days after the submission was received.

What is the product code of K051322?

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