Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

BYP — Predicate Candidate Screening

25 FDA 510(k) clearances under this product code; the 50 most recent screened below.

32 daysmedian FDA review time

85 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days
K955657	NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE	North State Plastics, Inc.	1996-03-12	91
K944512	TRUZONE PFM DISPOSABLE MOUTHPIECE	Monaghan Medical Corp.	1994-11-02	48
K893791	BREATHING MOUTHPIECE	Diemolding Corp.	1989-06-23	32
K872037	AEROCHAMBER	Monaghan Medical Corp.	1987-07-24	58
K865093	SAFE-T-SHIELD MOUTHPIECE	Medi Nuclear Corp., Inc.	1987-01-15	16
K863049	INHALATION AID	Boehringer Ingelheim Pharmaceuticals, Inc.	1986-10-15	64
K862788	MP-4400 MOUTHPIECE-FLANGE SEAL	Medipart Jerry Alexander	1986-08-01	9
K853266	PLASTIC MOUTH BARRIER HSV-I	Westmark Enterprises, Inc.	1985-10-29	85
K853572	MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410	Medipart Jerry Alexander	1985-10-29	64
K853574	MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411	Medipart Jerry Alexander	1985-10-29	64
K853575	MEDIPART MOUTHPIECE MP-1010	Medipart Jerry Alexander	1985-10-29	64
K853402	E-Z-GUARD MOUTHPIECE	E-Z-Em, Inc.	1985-10-23	72
K840459	IMPROVED MOUTHPIECE	Kinetix	1984-02-17	15
K833420	KINETIX MOUTHPIECE	Kinetix	1984-01-10	99
K822437	MONAGHAN AEROCHAMBER	Monaghan Medical Corp.	1982-11-03	82
K821128	DISPOSABLE THERMOPLASTIC RUBBER MOUTH	Airlife, Inc.	1982-05-13	23
K810793	MOUTHPIECE, BREATHING	Dhd Medical Products Div. Diemolding Corp.	1981-05-05	43
K803069	SHELL KRATON THERMO-PLASTIC RUBBER COMP.	Warren E. Collins, Inc.	1980-12-22	17
K791537	DISPOSABLE MOUTHPIECE	Hospitak, Inc.	1979-09-07	28
K790933	MOUTHPIECE M-187	Mem Medical, Inc.	1979-05-21	6
K790931	CORRUGATED TUBE WITH MOUTHPIECE	Mem Medical, Inc.	1979-05-21	6
K790932	AEROSOL MOUTHPIECE NO. M-091	Mem Medical, Inc.	1979-05-21	6
K790066	MOUTHPIECE, UNIVERSAL	Airlife, Inc.	1979-02-06	25
K770586	UNIVERSAL MOUTHPIECE, #750	Surgicot, Inc.	1977-04-05	8
K761297	MOUTHPIECE SEAL	Oem Medical Div.	1977-01-03	13

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda