Product Code: BYT FDA class 2 21 CFR 868.5935

Ventilator, External Body, Negative Pressure, Adult (Cuirass)

Anesthesiology

The Ventilator, External Body, Negative Pressure, Adult (Cuirass) is a device that applies intermittent negative pressure to the chest and abdomen using a rigid shell (cuirass), creating a pressure gradient that draws air into the lungs without the need for an endotracheal tube. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BYT, regulated under 21 CFR 868.5935 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: BYT
Device Class: FDA class 2
Regulation Number: 868.5935
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 21 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K082657	RTX RESPIRATOR	Oct 08, 2008	Substantially Equivalent	Medivent Limited
K072290	PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS	May 29, 2008	Substantially Equivalent	Dima Italia Srl
K924341	HAYEK OSCILLATOR(TM)	Jul 21, 1993	Substantially Equivalent	Respironics, Inc.
K910947	NEV-10 NEGATIVE PRESSURE VENTILATOR	Jun 03, 1991	Substantially Equivalent	Lifecare Services, Inc.
K905530	PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM	Mar 01, 1991	Substantially Equivalent	Puritan Bennett Corp.
K902764	EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM	Nov 19, 1990	Substantially Equivalent	J. H. Emerson Co.
K903745	THE HAYEK OSCILLATOR	Nov 09, 1990	Substantially Equivalent	Flexco Medical Instruments
K902300	EASY BREATHER MODEL 100 ACCESSORIES	Jul 19, 1990	Substantially Equivalent	Progressive Productions , Ltd.
K895849	RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM	Dec 22, 1989	Substantially Equivalent	Respironics, Inc.
K894649	EMERSON 33-CR CHEST RESPIRATOR	Oct 13, 1989	Substantially Equivalent	Emerson Intl. Co.
K893213	EASY BREATHER MODEL 100	Aug 04, 1989	Substantially Equivalent	Progressive Productions , Ltd.
K881808	EMERSON CHEST RESPIRATOR, MODEL 33-CRE	Aug 04, 1988	Substantially Equivalent	J. H. Emerson Co.
K881689	LINDLEY II RESUSCITATOR	Jul 08, 1988	Substantially Equivalent	Lindley Resuscitator, Inc.
K863300	Q101 DIAGNOSTIC SPIROMETER	Nov 13, 1986	Substantially Equivalent	Quinton, Inc.
K860692	PTR MK II VENTILATOR	May 21, 1986	Substantially Equivalent	Bear Medical Systems, Inc.
K840885	LAKEVILLE BODY VENTILATOR	Jul 12, 1984	Substantially Equivalent	Edwards Ventilator Co.
K841090	VENTILATOR EXTERNAL BODY NEGATIVE PRESS	May 30, 1984	Substantially Equivalent	Porta-Lung Co.
K832176	NEGATIVE PRESSURE CHEST RESPIRATOR PUMP	Sep 12, 1983	Substantially Equivalent	J. H. Emerson Co.
K813326	TROCKI BODY VENTRILATOR	Dec 22, 1981	Substantially Equivalent	L.T.D. 3 Co.
K792673	CAM-10 CUIRASS SHELL	Jan 11, 1980	Substantially Equivalent	Lifecare Services, Inc.
K791406	CAM-10 CHEST SHELL	Aug 10, 1979	Substantially Equivalent	Lifecare Services, Inc.