Product Code: BYF FDA class 1 21 CFR 868.5600

Mask, Oxygen, Low Concentration, Venturi

Anesthesiology

The Mask, Oxygen, Low Concentration, Venturi is a face mask that uses the Venturi principle to entrain a precise, controlled concentration of oxygen mixed with room air for delivery to patients requiring supplemental oxygen therapy at specific, predictable fractions. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BYF, regulated under 21 CFR 868.5600 in the Anesthesiology specialty.

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510(k)s

FEI Numbers

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Basic Information

Product Code: BYF
Device Class: FDA class 1
Regulation Number: 868.5600
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K955483	TRACH MASK MODEL (245, 246)	Feb 28, 1996	Substantially Equivalent	Hospitak, Inc.
K951652	VENTIMASK MK IV	Apr 27, 1995	Substantially Equivalent	Flexicare Medical, Ltd.
K894457	CARNATION TRACHEOSTOMY MASKS	Oct 13, 1989	Substantially Equivalent	Dadsun Corp., Ltd.
K860873	VENTURI MASK/ADULT & PAEDIATRIC	Mar 20, 1986	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K860874	VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC	Mar 19, 1986	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K852618	OXY-DIAL	Sep 18, 1985	Substantially Equivalent	Ashai Co. , Ltd.
K832725	DUAL DIAL VENTURI STYLE MASK	Sep 20, 1983	Substantially Equivalent	Airlife, Inc.
K812066	PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN	Aug 03, 1981	Substantially Equivalent	Airlife, Inc.
K810947	AIR ENTRAINMENT TRACH T	Jun 02, 1981	Substantially Equivalent	Airlife, Inc.
K810946	ADULT & PEDIATRIC TRACHEOSTOMY MASKS	Jun 02, 1981	Substantially Equivalent	Airlife, Inc.
K810373	VENTURI MASK/DELIVERY SYSTEM #'S	Mar 17, 1981	Substantially Equivalent	Todd Industries, Inc.
K810430	VENTURI MASK/DELIVERY SYSTEM #6078	Mar 13, 1981	Substantially Equivalent	Todd Industries, Inc.
K790146	MASK, PERCENTO	Feb 06, 1979	Substantially Equivalent	Airlife, Inc.
K781325	MARKII VENTIMASKS	Sep 27, 1978	Substantially Equivalent	Vickers America Medical Corp.
K780626	VENTURI OXYGEN MASK	May 26, 1978	Substantially Equivalent	Hospitak, Inc.
K780011	CONCHAPAK OXYGEN DILUTER	Feb 02, 1978	Substantially Equivalent	Respiratory Care, Inc.
K772127	OXYGEN MASK, AIR-ENTRAINMENT	Jan 03, 1978	Substantially Equivalent	Salter Labs
K771385	2 JET SET	Aug 04, 1977	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K760518	ADAPTER, PER-CEN-TOX-BODY	Sep 03, 1976	Substantially Equivalent	Landmark Plastics