Product Code: BYP FDA class 1 21 CFR 868.5620

Mouthpiece, Breathing

Anesthesiology

The Mouthpiece, Breathing is a device that interfaces with the patient's mouth during pulmonary function testing, respiratory therapy, or spirometry, forming a seal to ensure all exhaled and inhaled gas passes through the measuring or treatment system. 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 BYP, regulated under 21 CFR 868.5620 in the Anesthesiology specialty.

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510(k)s

FEI Numbers

162

Registration Numbers

162

Unique Applicants

Years Active

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Basic Information

Product Code: BYP
Device Class: FDA class 1
Regulation Number: 868.5620
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

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 25 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K955657	NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE	Mar 12, 1996	Substantially Equivalent	North State Plastics, Inc.
K944512	TRUZONE PFM DISPOSABLE MOUTHPIECE	Nov 02, 1994	Substantially Equivalent	Monaghan Medical Corp.
K893791	BREATHING MOUTHPIECE	Jun 23, 1989	Substantially Equivalent	Diemolding Corp.
K872037	AEROCHAMBER	Jul 24, 1987	Substantially Equivalent	Monaghan Medical Corp.
K865093	SAFE-T-SHIELD MOUTHPIECE	Jan 15, 1987	Substantially Equivalent	Medi Nuclear Corp., Inc.
K863049	INHALATION AID	Oct 15, 1986	Substantially Equivalent	Boehringer Ingelheim Pharmaceuticals, Inc.
K862788	MP-4400 MOUTHPIECE-FLANGE SEAL	Aug 01, 1986	Substantially Equivalent	Medipart Jerry Alexander
K853575	MEDIPART MOUTHPIECE MP-1010	Oct 29, 1985	Substantially Equivalent	Medipart Jerry Alexander
K853574	MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411	Oct 29, 1985	Substantially Equivalent	Medipart Jerry Alexander
K853572	MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410	Oct 29, 1985	Substantially Equivalent	Medipart Jerry Alexander
K853266	PLASTIC MOUTH BARRIER HSV-I	Oct 29, 1985	Substantially Equivalent	Westmark Enterprises, Inc.
K853402	E-Z-GUARD MOUTHPIECE	Oct 23, 1985	Substantially Equivalent	E-Z-Em, Inc.
K840459	IMPROVED MOUTHPIECE	Feb 17, 1984	Substantially Equivalent	Kinetix
K833420	KINETIX MOUTHPIECE	Jan 10, 1984	Substantially Equivalent	Kinetix
K822437	MONAGHAN AEROCHAMBER	Nov 03, 1982	Substantially Equivalent	Monaghan Medical Corp.
K821128	DISPOSABLE THERMOPLASTIC RUBBER MOUTH	May 13, 1982	Substantially Equivalent	Airlife, Inc.
K810793	MOUTHPIECE, BREATHING	May 05, 1981	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K803069	SHELL KRATON THERMO-PLASTIC RUBBER COMP.	Dec 22, 1980	Substantially Equivalent	Warren E. Collins, Inc.
K791537	DISPOSABLE MOUTHPIECE	Sep 07, 1979	Substantially Equivalent	Hospitak, Inc.
K790933	MOUTHPIECE M-187	May 21, 1979	Substantially Equivalent	Mem Medical, Inc.
K790932	AEROSOL MOUTHPIECE NO. M-091	May 21, 1979	Substantially Equivalent	Mem Medical, Inc.
K790931	CORRUGATED TUBE WITH MOUTHPIECE	May 21, 1979	Substantially Equivalent	Mem Medical, Inc.
K790066	MOUTHPIECE, UNIVERSAL	Feb 06, 1979	Substantially Equivalent	Airlife, Inc.
K770586	UNIVERSAL MOUTHPIECE, #750	Apr 05, 1977	Substantially Equivalent	Surgicot, Inc.
K761297	MOUTHPIECE SEAL	Jan 03, 1977	Substantially Equivalent	Oem Medical Div.