Product Code: CBH
FDA class 1
21 CFR 868.5770
Device, Fixation, Tracheal Tube
Anesthesiology
The Tracheal Tube Fixation Device is an anesthesiology device used to secure an endotracheal tube in position after insertion, preventing unintentional displacement or movement of the tube that could compromise airway management. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CBH, regulated under 21 CFR 868.5770, within the Anesthesiology medical specialty. No special flags apply to this device.
510(k)s
47
FEI Numbers
142
Registration Numbers
142
Unique Applicants
33
Years Active
36
Basic Information
- Product Code
- CBH
- Device Class
- FDA class 1
- Regulation Number
- 868.5770
- 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
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Related 510(k) Clearances
This FDA classification is associated with 47 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K140097 | AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM | Sep 24, 2014 | Substantially Equivalent | APPLIED MEDICAL TECHNOLOGY, INC. |
| K964399 | DALE ENDOTRACHEAL TUBE HOLDER 270/280 | Jan 28, 1997 | Substantially Equivalent | DALE MEDICAL PRODUCTS, INC. |
| K942529 | HCI TUBE STABILIZER | Jun 14, 1995 | Substantially Equivalent | HEALTH CARE CONTRACTS, INC. |
| K951491 | DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS | Apr 24, 1995 | Substantially Equivalent | DALE MEDICAL PRODUCTS, INC. |
| K950930 | TRACHE-TITE | Mar 22, 1995 | Substantially Equivalent | THE VARNER GROUP, INC. |
| K950318 | FLEX BLUE | Feb 13, 1995 | Substantially Equivalent | KING SYSTEMS CORP. |
| K942395 | ENDOTRACHEAL TUBE HOLDER | Jun 30, 1994 | Substantially Equivalent | S.T.I. MEDICAL PRODUCTS CORP. |
| K934288 | HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR | Jun 09, 1994 | Substantially Equivalent | NEO-TECH, INC. |
| K942016 | TRACH TIE, VENTILATOR TUBING HOLDER | May 24, 1994 | Substantially Equivalent | GARRETT MEDICAL PRODUCTS |
| K941384 | TRAKEEZ | Apr 19, 1994 | Substantially Equivalent | ERGOMED, INC. |
| K940448 | NETOH ENDOTRACHEAL TUBE HOLDER | Feb 22, 1994 | Substantially Equivalent | MEDICAL ACCESSORY SERVICES, INC. |
| K936094 | PREPARE LOCK | Feb 03, 1994 | Substantially Equivalent | PREPARE, INC. |
| K935171 | STABILTRACH | Dec 02, 1993 | Substantially Equivalent | B & B MEDICAL TECHNOLOGIES, INC. |
| K933420 | BREATHING TUBE SUPPORT | Oct 13, 1993 | Substantially Equivalent | BLAKE MEDICAL, INC. |
| K933781 | ANTI-DISCONNECTION MECHANISM | Sep 22, 1993 | Substantially Equivalent | HAMMER-PLANE, INC. |
| K925386 | ADHESIVE E.T. TAPE | Apr 19, 1993 | Unknown | B & B MEDICAL TECHNOLOGIES, INC. |
| K924551 | ENDO TRACHEA TUBE FIXATION | Dec 08, 1992 | Substantially Equivalent | M. IMONTI AND ASSOCIATES INC., |
| K921698 | CN ENDOTRACHEAL TUBE HOLDER | Sep 15, 1992 | Substantially Equivalent | N-C-N PRODUCTS CO. |
| K922657 | AGA TRACH TIES | Jul 02, 1992 | Substantially Equivalent | AGA MEDICAL PRODUCTS, INC. |
| K920691 | THE LEWIS TUBE HOLDER | Mar 18, 1992 | Substantially Equivalent | R. LEWIS, INC. |
| K912884 | E.T. TAPE II | Jul 31, 1991 | Substantially Equivalent | B & B MEDICAL TECHNOLOGIES, INC. |
| K905231 | DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT. | Jan 14, 1991 | Substantially Equivalent | DALE MEDICAL PRODUCTS, INC. |
| K904974 | TRACH COLLAR | Jan 11, 1991 | Substantially Equivalent | ROTEK CORP. |
| K903539 | SALTER LABS MODEL #1015 | Dec 17, 1990 | Substantially Equivalent | SALTER LABS |
| K902896 | 49-610 NIKO-NOSE FIXATION TAPE | Oct 23, 1990 | Substantially Equivalent | NIKOMED U.S.A., INC. |
| K902604 | BLAKE MEDICAL BREATHING TUBE SUPPORT | Oct 02, 1990 | Substantially Equivalent | BLAKE MEDICAL, INC. |
| K900912 | BABY E.T. TAPE II | Aug 03, 1990 | Substantially Equivalent | B & B MEDICAL TECHNOLOGIES, INC. |
| K902065 | E.T. TAPE II | Jul 23, 1990 | Substantially Equivalent | B & B MEDICAL TECHNOLOGIES, INC. |
| K900787 | NASAL E.T. TAPE | Mar 16, 1990 | Substantially Equivalent | B & B MEDICAL TECHNOLOGIES, INC. |
| K900236 | ET-RESTRAINT CAT. # ER 4000 | Feb 02, 1990 | Substantially Equivalent | VENTLAB CORP. |
| K882891 | A.C.I. TRACH TIE | Sep 19, 1988 | Substantially Equivalent | AUXILIARY CARE, INC. |
| K882079 | RESPIRONIC'S INFANT SECUREEASY | Aug 19, 1988 | Substantially Equivalent | RESPIRONICS, INC. |
| K882694 | FIXATION DEVICE, TRACH TUBE | Aug 15, 1988 | Substantially Equivalent | BIOSEAL |
| K872832 | TRACH COLLAR | Sep 04, 1987 | Substantially Equivalent | ROTEK CORP. |
| K872277 | TRAKEFIT TRACHEOSTOMY TUBE HOLDER | Jul 21, 1987 | Substantially Equivalent | ACKRAD LABORATORIES |
| K871560 | BABY E.T. TAPE(TM) | May 22, 1987 | Substantially Equivalent | B & B MEDICAL TECHNOLOGIES, INC. |
| K864526 | ENDOTRACHEAL TUBE HOLDER | May 21, 1987 | Substantially Equivalent | MATHEW MEDICAL CO. |
| K862084 | E. T. TAPE ENDOTRACHEAL TUBE HOLDER | Jun 05, 1986 | Substantially Equivalent | B & B MEDICAL TECHNOLOGIES, INC. |
| K860845 | RESPIRONICS SECUREASY | Mar 13, 1986 | Substantially Equivalent | RESPIRONICS, INC. |
| K851874 | OR TUBE RESTRAINT | Aug 08, 1985 | Substantially Equivalent | KINETIC CONCEPTS, INC. |
| K843790 | TRACHEAL TUBE FIXATION DEVICE | Mar 11, 1985 | Substantially Equivalent | LAERDAL CALIFORNIA, INC. |
| K830706 | E.T. STRAP #6000 | Apr 28, 1983 | Substantially Equivalent | RND MEDICAL PRODUCTS, INC. |
| K822794 | RESPIRONICS ENDO TUBE CONTROL SYS | Oct 22, 1982 | Substantially Equivalent | RESPIRONICS, INC. |
| K811185 | N-D0-SURE | Jun 02, 1981 | Substantially Equivalent | ACKRAD LABORATORIES |
| K810737 | ENDOTRACHEAL TUBE HOLDER | Apr 17, 1981 | Substantially Equivalent | AIRCARE SYSTEMS |
| K802601 | ENDOTRACHEAL TUBE HOLDER | Dec 18, 1980 | Substantially Equivalent | HUDSON OXYGEN THERAPY SALES CO. |
| K781695 | LUBE-LOK | Nov 01, 1978 | Substantially Equivalent | OLYMPIC MEDICAL CORP. |
FEI Numbers
This FDA classification entry is associated with 142 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 142 registration numbers. Click on an entry to view related FDA registrations.