Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

CBH — Predicate Candidate Screening

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

49 daysmedian FDA review time

175 days90th percentile

47clearances measured

K-number	Device	Applicant	Decided	Review days
K140097	AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM	Applied Medical Technology, Inc.	2014-09-24	253
K964399	DALE ENDOTRACHEAL TUBE HOLDER 270/280	Dale Medical Products, Inc.	1997-01-28	85
K942529	HCI TUBE STABILIZER	Health Care Contracts, Inc.	1995-06-14	383
K951491	DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TAB	Dale Medical Products, Inc.	1995-04-24	24
K950930	TRACHE-TITE	The Varner Group, Inc.	1995-03-22	21
K950318	FLEX BLUE	King Systems Corp.	1995-02-13	18
K942395	ENDOTRACHEAL TUBE HOLDER	S.T.I. Medical Products Corp.	1994-06-30	42
K934288	HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR	Neo-Tech, Inc.	1994-06-09	280
K942016	TRACH TIE, VENTILATOR TUBING HOLDER	Garrett Medical Products	1994-05-24	28
K941384	TRAKEEZ	Ergomed, Inc.	1994-04-19	28
K940448	NETOH ENDOTRACHEAL TUBE HOLDER	Medical Accessory Services, Inc.	1994-02-22	21
K936094	PREPARE LOCK	Prepare, Inc.	1994-02-03	43
K935171	STABILTRACH	B&B Medical Technologies, Inc.	1993-12-02	37
K933420	BREATHING TUBE SUPPORT	Blake Medical, Inc.	1993-10-13	92
K933781	ANTI-DISCONNECTION MECHANISM	Hammer-Plane, Inc.	1993-09-22	49
K925386	ADHESIVE E.T. TAPE	B&B Medical Technologies, Inc.	1993-04-19	175
K924551	ENDO TRACHEA TUBE FIXATION	M. Imonti and Associates Inc.,	1992-12-08	90
K921698	CN ENDOTRACHEAL TUBE HOLDER	N-C-N Products Co.	1992-09-15	160
K922657	AGA TRACH TIES	Aga Medical Products, Inc.	1992-07-02	29
K920691	THE LEWIS TUBE HOLDER	R. Lewis, Inc.	1992-03-18	33
K912884	E.T. TAPE II	B&B Medical Technologies, Inc.	1991-07-31	30
K905231	DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT.	Dale Medical Products, Inc.	1991-01-14	55
K904974	TRACH COLLAR	Rotek Corp.	1991-01-11	80
K903539	SALTER LABS MODEL #1015	Salter Labs	1990-12-17	132
K902896	49-610 NIKO-NOSE FIXATION TAPE	Nikomed U.S.A., Inc.	1990-10-23	112
K902604	BLAKE MEDICAL BREATHING TUBE SUPPORT	Blake Medical, Inc.	1990-10-02	112
K900912	BABY E.T. TAPE II	B&B Medical Technologies, Inc.	1990-08-03	157
K902065	E.T. TAPE II	B&B Medical Technologies, Inc.	1990-07-23	76
K900787	NASAL E.T. TAPE	B&B Medical Technologies, Inc.	1990-03-16	24
K900236	ET-RESTRAINT CAT. # ER 4000	Ventlab Corp.	1990-02-02	16
K882891	A.C.I. TRACH TIE	Auxiliary Care, Inc.	1988-09-19	70
K882079	RESPIRONIC'S INFANT SECUREEASY	Respironics, Inc.	1988-08-19	94
K882694	FIXATION DEVICE, TRACH TUBE	Bioseal	1988-08-15	49
K872832	TRACH COLLAR	Rotek Corp.	1987-09-04	49
K872277	TRAKEFIT TRACHEOSTOMY TUBE HOLDER	Ackrad Laboratories	1987-07-21	36
K871560	BABY E.T. TAPE(TM)	B&B Medical Technologies, Inc.	1987-05-22	30
K864526	ENDOTRACHEAL TUBE HOLDER	Mathew Medical Co.	1987-05-21	185
K862084	E. T. TAPE ENDOTRACHEAL TUBE HOLDER	B&B Medical Technologies, Inc.	1986-06-05	3
K860845	RESPIRONICS SECUREASY	Respironics, Inc.	1986-03-13	7
K851874	OR TUBE RESTRAINT	Kinetic Concepts, Inc.	1985-08-08	101
K843790	TRACHEAL TUBE FIXATION DEVICE	Laerdal California, Inc.	1985-03-11	165
K830706	E.T. STRAP #6000	Rnd Medical Products, Inc.	1983-04-28	52
K822794	RESPIRONICS ENDO TUBE CONTROL SYS	Respironics, Inc.	1982-10-22	36
K811185	N-D0-SURE	Ackrad Laboratories	1981-06-02	34
K810737	ENDOTRACHEAL TUBE HOLDER	Aircare Systems	1981-04-17	30
K802601	ENDOTRACHEAL TUBE HOLDER	Hudson Oxygen Therapy Sales Co.	1980-12-18	58
K781695	LUBE-LOK	Olympic Medical Corp.	1978-11-01	22

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