Life Oxygenpac 6/12 LPM

Q: What is the product code of K910435?

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

FDA 510(k) K910435 · Life Corp.

Substantially Equivalent

510(k) numberK910435

Submission

Device name: Life Oxygenpac 6/12 LPM
Applicant: Life Corp.
Menomonee Falls, WI, US
Received: January 31, 1991
Decision date: June 17, 1991
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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)	Device	Applicant	Decision
K242769	VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)BTL · Traditional	Draegerwerk AG & CO Kgaa	04/04/2025SE
K221634	Oxymag - Transport and Emergency VentilatorBTL · Traditional	Magnamed Tecnologia Medica S/A	05/24/2023SE
K202219	VORTRAN GO2VENT with PEEP ValveBTL · Traditional	Vortran Medical Technology 1, Inc.	02/11/2021SE
K193191	MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagBTL · Traditional	Weinmann Emergency Medical Technology GmbH + Co.…	11/20/2020SE
K182956	Puffin Lite Infant Resuscitation SystemBTL · Special	International Biomedical	01/18/2019SE
K173373	SafeT T-Piece ResuscitatorBTL · Traditional	Ventlab, LLC	11/16/2018SE
K161420	Moves SLCBTL · Traditional	Thornhill Research, Inc.	06/06/2017SE
K162968	Vortran GO2VENTBTL · Traditional	Vortran Medical Technology 1, Inc.	04/10/2017SE
K141595	O-Two E700,O-TWO E600,O-TWO E500BTL · Traditional	O-Two Medical Technologies, Inc.	03/16/2015SE
K142096	T-Piece ResuscitatorBTL · Traditional	Mercury Medical	10/17/2014SE

More from Mercury Medical

510(k)	Device	Decision
K910699	LIFE-02 (Non-Refillable Cylinder)BTL · Traditional	06/18/1991SE
K910434	Life Oxygenpac for Trained Medical PersonnelBTL · Traditional	06/17/1991SE
K910201	Life O2BTL · Traditional	02/01/1991SE
K855092	Life Corp. Oxygen PacBTL · Traditional	01/21/1986SE

Questions and answers

When was Life Oxygenpac 6/12 LPM cleared by the FDA?

Life Oxygenpac 6/12 LPM (K910435) received a 510(k) decision of Substantially Equivalent on June 17, 1991, 137 days after the submission was received.

What is the product code of K910435?

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