Product Code: BSJ FDA class 1 21 CFR 868.5550

Mask, Gas, Anesthetic

Anesthesiology

The Mask, Gas, Anesthetic is a face mask used to deliver anesthetic gases and oxygen to a patient during the induction or maintenance of general anesthesia, creating a sealed interface over the nose and mouth. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is BSJ, regulated under 21 CFR 868.5550 in the Anesthesiology specialty.

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510(k)s

FEI Numbers

158

Registration Numbers

158

Unique Applicants

Years Active

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Basic Information

Product Code: BSJ
Device Class: FDA class 1
Regulation Number: 868.5550
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

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 51 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K163277	SuperNO2VA Device	Oct 13, 2017	Substantially Equivalent	Revolutionary Medical Devices, Inc.
K953107	ANESTHESIA/RESPIRATORY FACE MASK	Aug 15, 1995	Substantially Equivalent	Medical Marketing Concepts
K953295	ANESTHESIA FACE MASK	Aug 11, 1995	Substantially Equivalent	Mallinckrodt Medical
K952689	BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK	Jul 11, 1995	Substantially Equivalent	Owens-Brigam Medical Co.
K951043	AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK	Jun 07, 1995	Substantially Equivalent	Promedic, Inc.
K950771	DISPOSABLE ADHESIVE FACE MASK	Mar 10, 1995	Substantially Equivalent	Advanced Warming Systems, Inc.
K945894	MASK, GAS, ANESTHETIC	Jan 27, 1995	Substantially Equivalent	Hans Rudolph, Inc.
K945440	DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK	Nov 08, 1994	Substantially Equivalent	Fvtnks
K944157	DISPOSABLE, PREFORMED FACE MASK	Oct 03, 1994	Substantially Equivalent	Meridian Medical Systems, Inc.
K932147	NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE	Aug 20, 1993	Substantially Equivalent	Hans Rudolph, Inc.
K932014	AMBU DISPOSABLE FACE MASK	Jun 22, 1993	Substantially Equivalent	Ambu, Inc.
K915558	IAS ANESTHESIA MASK	Apr 08, 1992	Substantially Equivalent	Ias
K903881	VENTLAB VENT-MASK, CAT# VR 0010/20/30	Sep 04, 1990	Substantially Equivalent	Ventlab Corp.
K902298	ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS	Aug 22, 1990	Substantially Equivalent	Rondex Products, Inc.
K891316	ANESTHESIA/RESPIRATORY DISPOSABLE MASK	Aug 21, 1989	Substantially Equivalent	Concord/Portex
K884157	MODIFIED TOUCH-ME-NOT MASK	Aug 21, 1989	Substantially Equivalent	Walt'S Products
K890795	RESPIRONICS SEALEASY II	Apr 20, 1989	Substantially Equivalent	Respironics, Inc.
K890108	MODIFIED CUSHION-FLEX(TM)	Jan 24, 1989	Substantially Equivalent	Life Design Systems, Inc.
K884387	CUSHION FLEX(TM)	Nov 17, 1988	Substantially Equivalent	Life Design Systems, Inc.
K882434	MASK, GAS, ANESTHETIC	Jun 30, 1988	Substantially Equivalent	Eastmed Enterprises, Inc.
K881393	RONDEX RESCUE MASK	Apr 25, 1988	Substantially Equivalent	Rondex Products, Inc.
K881067	NON CONDUCTIVE, SINGLE USE ANESTHESIA FACE MASK	Mar 24, 1988	Substantially Equivalent	Medesign, Inc.
K880682	MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP	Mar 21, 1988	Substantially Equivalent	King Systems Corp.
K874746	SEALFLEX MASK	Dec 21, 1987	Substantially Equivalent	Engineered Medical Systems
K872015	SPIRASEAL(TM) FACE MASK (VARIOUS SIZES)	Jun 17, 1987	Substantially Equivalent	Brigam, Inc.
K871851	RIBBED CUSHION MASK	Jun 08, 1987	Substantially Equivalent	Engineered Medical Systems
K862784	MP-XMO DISPOSABLE FACE MASK	Aug 01, 1986	Substantially Equivalent	Medipart Jerry Alexander
K862783	MP-XMV DISPOSABLE FACE MASK	Aug 01, 1986	Substantially Equivalent	Medipart Jerry Alexander
K862782	MP-XML DISPOSABLE FACE MASK	Aug 01, 1986	Substantially Equivalent	Medipart Jerry Alexander
K862781	MP-XMM DISPOSABLE FACE MASK	Aug 01, 1986	Substantially Equivalent	Medipart Jerry Alexander
K860686	FACEGLOV,ANESTHETIC GAS MASK	Apr 30, 1986	Substantially Equivalent	Loran , Ltd.
K853785	SERIES 2000 MEDS MASK	Dec 03, 1985	Substantially Equivalent	Med Systems
K854161	SUR-FIT FACE MASK	Nov 05, 1985	Substantially Equivalent	Anesthesia Respiratory Technology, Inc.
K850263	PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY	Mar 25, 1985	Substantially Equivalent	Plasmedics, Inc.
K844494	MEDIPART FACE MASK MP-XM	Dec 04, 1984	Substantially Equivalent	Medipart Jerry Alexander
K844493	MEDIPART FACE MASK & FILTER MP-30XM	Dec 04, 1984	Substantially Equivalent	Medipart Jerry Alexander
K843169	CUSHION-FLEX TM	Aug 20, 1984	Substantially Equivalent	Life Design Systems, Inc.
K842472	DRYDEN INFLATABLE MASK	Jul 06, 1984	Substantially Equivalent	Dryden Corp.
K841240	DISPOSABLE ANESTHESIA MASK	Apr 05, 1984	Substantially Equivalent	Hospitak, Inc.
K840535	DISPOS. ANESTHESIA FACE MASK	Feb 21, 1984	Substantially Equivalent	Marquest Medical Products, Inc.
K840452	PREMIUM DABM DISPOS. ANES. BREATH MASK	Feb 17, 1984	Substantially Equivalent	Ohio Medical Products
K834536	CRYSTALCONE FACE MASK-MED-W/HOOKRING	Jan 25, 1984	Substantially Equivalent	Warne Surgical Products, Ltd.
K834454	PAEDIATRIC FACE MASK 1-3 W/WO RING	Jan 18, 1984	Substantially Equivalent	Warne Surgical Products, Ltd.
K831713	NON CONDUCTIVE ANESTHESIA FACEMASK	Jul 07, 1983	Substantially Equivalent	Vital Signs, Inc.
K830982	MASKS	May 09, 1983	Substantially Equivalent	Medovations, Inc.
K821045	NON CONDUCTIVE PEDIATRIC ANES. FACE	Apr 26, 1982	Substantially Equivalent	Vital Signs, Inc.
K810990	OHIO NONCONDUCTIVE RBS TYPE FACE MASK	Apr 23, 1981	Substantially Equivalent	Ohio Medical Products
K803185	NON-CONDUCTIVE ANESTHESIA FACE MASK	Jan 05, 1981	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K801251	NON-CONDUCTIVE, SINGLE USE FACE MASK #55	Jun 04, 1980	Substantially Equivalent	Vital Signs, Inc.
K790638	ACCUTRON POLLUTION REDUCER	May 25, 1979	Substantially Equivalent	Parker Laboratories, Inc.
K782163	THE BLUE MASK	Mar 01, 1979	Substantially Equivalent	Collectovac, Inc.