Atlas FDA

CBH

47 FDA 510(k) clearances · Product code

49 daysmedian time to decision
175 days90th percentile
47clearances measured

FDA profile

Official device name
Device, Fixation, Tracheal Tube
Device class
Class I (low risk)
Regulation
21 CFR 868.5770
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2021: 27 · 2022: 47 · 2023: 22 · 2024: 20 · 2025: 66 · 2026: 59
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM (K140097)Applied Medical Technology, Inc.2014-09-24
DALE ENDOTRACHEAL TUBE HOLDER 270/280 (K964399)Dale Medical Products, Inc.1997-01-28
HCI TUBE STABILIZER (K942529)Health Care Contracts, Inc.1995-06-14
DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS (K951491)Dale Medical Products, Inc.1995-04-24
TRACHE-TITE (K950930)The Varner Group, Inc.1995-03-22
FLEX BLUE (K950318)King Systems Corp.1995-02-13
ENDOTRACHEAL TUBE HOLDER (K942395)S.T.I. Medical Products Corp.1994-06-30
HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR (K934288)Neo-Tech, Inc.1994-06-09
TRACH TIE, VENTILATOR TUBING HOLDER (K942016)Garrett Medical Products1994-05-24
TRAKEEZ (K941384)Ergomed, Inc.1994-04-19
NETOH ENDOTRACHEAL TUBE HOLDER (K940448)Medical Accessory Services, Inc.1994-02-22
PREPARE LOCK (K936094)Prepare, Inc.1994-02-03
STABILTRACH (K935171)B&B Medical Technologies, Inc.1993-12-02
BREATHING TUBE SUPPORT (K933420)Blake Medical, Inc.1993-10-13
ANTI-DISCONNECTION MECHANISM (K933781)Hammer-Plane, Inc.1993-09-22
ADHESIVE E.T. TAPE (K925386)B&B Medical Technologies, Inc.1993-04-19
ENDO TRACHEA TUBE FIXATION (K924551)M. Imonti and Associates Inc.,1992-12-08
CN ENDOTRACHEAL TUBE HOLDER (K921698)N-C-N Products Co.1992-09-15
AGA TRACH TIES (K922657)Aga Medical Products, Inc.1992-07-02
THE LEWIS TUBE HOLDER (K920691)R. Lewis, Inc.1992-03-18
E.T. TAPE II (K912884)B&B Medical Technologies, Inc.1991-07-31
DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT. (K905231)Dale Medical Products, Inc.1991-01-14
TRACH COLLAR (K904974)Rotek Corp.1991-01-11
SALTER LABS MODEL #1015 (K903539)Salter Labs1990-12-17
49-610 NIKO-NOSE FIXATION TAPE (K902896)Nikomed U.S.A., Inc.1990-10-23
BLAKE MEDICAL BREATHING TUBE SUPPORT (K902604)Blake Medical, Inc.1990-10-02
BABY E.T. TAPE II (K900912)B&B Medical Technologies, Inc.1990-08-03
E.T. TAPE II (K902065)B&B Medical Technologies, Inc.1990-07-23
NASAL E.T. TAPE (K900787)B&B Medical Technologies, Inc.1990-03-16
ET-RESTRAINT CAT. # ER 4000 (K900236)Ventlab Corp.1990-02-02
A.C.I. TRACH TIE (K882891)Auxiliary Care, Inc.1988-09-19
RESPIRONIC'S INFANT SECUREEASY (K882079)Respironics, Inc.1988-08-19
FIXATION DEVICE, TRACH TUBE (K882694)Bioseal1988-08-15
TRACH COLLAR (K872832)Rotek Corp.1987-09-04
TRAKEFIT TRACHEOSTOMY TUBE HOLDER (K872277)Ackrad Laboratories1987-07-21
BABY E.T. TAPE(TM) (K871560)B&B Medical Technologies, Inc.1987-05-22
ENDOTRACHEAL TUBE HOLDER (K864526)Mathew Medical Co.1987-05-21
E. T. TAPE ENDOTRACHEAL TUBE HOLDER (K862084)B&B Medical Technologies, Inc.1986-06-05
RESPIRONICS SECUREASY (K860845)Respironics, Inc.1986-03-13
OR TUBE RESTRAINT (K851874)Kinetic Concepts, Inc.1985-08-08
TRACHEAL TUBE FIXATION DEVICE (K843790)Laerdal California, Inc.1985-03-11
E.T. STRAP #6000 (K830706)Rnd Medical Products, Inc.1983-04-28
RESPIRONICS ENDO TUBE CONTROL SYS (K822794)Respironics, Inc.1982-10-22
N-D0-SURE (K811185)Ackrad Laboratories1981-06-02
ENDOTRACHEAL TUBE HOLDER (K810737)Aircare Systems1981-04-17
ENDOTRACHEAL TUBE HOLDER (K802601)Hudson Oxygen Therapy Sales Co.1980-12-18
LUBE-LOK (K781695)Olympic Medical Corp.1978-11-01

Track CBH automatically

Every clearance here is in the API, with alerts when new ones post.