Product Code: JAY FDA class 1 21 CFR 868.5280

Support, Breathing Tube

Anesthesiology

A breathing tube support is a device used to hold and stabilize endotracheal or tracheostomy tubes in proper position, preventing accidental dislodgement and reducing patient discomfort during airway management. It is classified as FDA Class 1, the lowest risk category, requiring only general controls and not subject to premarket notification requirements. The product code is JAY, regulated under 21 CFR 868.5280, within the Anesthesiology medical specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: JAY
Device Class: FDA class 1
Regulation Number: 868.5280
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 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K944988	CUSTOM MEDICAL SUSPENSION STRAP	Jan 27, 1995	Substantially Equivalent	Custom Medical Specialties, Inc.
K873491	BLOCK, BITE, INTUBATION	Oct 20, 1987	Substantially Equivalent	B&B Medical Technologies, Inc.
K860583	DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315	Feb 21, 1986	Substantially Equivalent	Dale Medical Products, Inc.
K850924	JEE FRAME (VENTILATOR CIRCUIT SUPPORT)	Jul 19, 1985	Substantially Equivalent	Vulcan Laboratories, Inc.
K850309	COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK	Feb 14, 1985	Substantially Equivalent	Ackrad Laboratories
K840844	ENDO-SECURE	Mar 16, 1984	Substantially Equivalent	Exidyne, Inc.
K834265	TRACH MATE	Jan 04, 1984	Substantially Equivalent	Tempe Biomedical, Inc.
K834089	COMFIT	Dec 29, 1983	Substantially Equivalent	Ackrad Laboratories
K833374	BITE-BLOCK	Nov 03, 1983	Substantially Equivalent	Sontek Industries, Inc.
K833361	TUBE-TITLE	Nov 03, 1983	Substantially Equivalent	Sontek Industries, Inc.
K833332	SCHULTZ ENDHOLD	Oct 31, 1983	Substantially Equivalent	Polyclinic Medical Center
K832946	DALE ENDOTRACHEAL TUBE HOLDER	Oct 14, 1983	Substantially Equivalent	Dale Medical Products, Inc.
K802675	ENDOTRACHEAL TUBE HOLDER	Nov 19, 1980	Substantially Equivalent	Respiratory Support Products, Inc.
K792148	ADJUSTABLE TUBE TREE FOR ANESTH. HOSES	Nov 15, 1979	Substantially Equivalent	Medical Innovations Corp.
K791781	TUBE-STRAP	Sep 19, 1979	Substantially Equivalent	Olympic Medical Corp.
K790410	ADULT ZEE-FRAME	Mar 22, 1979	Substantially Equivalent	Equilibrated Bio Systems, Inc.
K781509	ZEE-FRAME	Sep 26, 1978	Substantially Equivalent	Equilibrated Bio Systems, Inc.
K770631	FLEX ARM BE 122, CLAMP 122-27	May 23, 1977	Substantially Equivalent	Instrumentation Industries, Inc.
K770628	CLAMP BE-152	May 23, 1977	Substantially Equivalent	Instrumentation Industries, Inc.