Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5770](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5770) → CBH — Device, Fixation, Tracheal Tube # CBH · Device, Fixation, Tracheal Tube _Anesthesiology · 21 CFR 868.5770 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH ## Overview - **Product Code:** CBH - **Device Name:** Device, Fixation, Tracheal Tube - **Regulation:** [21 CFR 868.5770](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5770) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification A tracheal tube fixation device is a device used to hold a tracheal tube in place, usually by means of straps or pinch rings. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. ## Recent Cleared Devices (20 of 47) Showing 20 most recent of 47 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K140097](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K140097.md) | AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM | Applied Medical Technology, Inc. | Sep 24, 2014 | SESE | | [K964399](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K964399.md) | DALE ENDOTRACHEAL TUBE HOLDER 270/280 | Dale Medical Products, Inc. | Jan 28, 1997 | SESE | | [K942529](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K942529.md) | HCI TUBE STABILIZER | Health Care Contracts, Inc. | Jun 14, 1995 | SESE | | [K951491](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K951491.md) | DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS | Dale Medical Products, Inc. | Apr 24, 1995 | SESE | | [K950930](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K950930.md) | TRACHE-TITE | The Varner Group, Inc. | Mar 22, 1995 | SESE | | [K950318](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K950318.md) | FLEX BLUE | King Systems Corp. | Feb 13, 1995 | SESE | | [K942395](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K942395.md) | ENDOTRACHEAL TUBE HOLDER | S.T.I. Medical Products Corp. | Jun 30, 1994 | SESE | | [K934288](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K934288.md) | HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR | Neo-Tech, Inc. | Jun 9, 1994 | SESE | | [K942016](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K942016.md) | TRACH TIE, VENTILATOR TUBING HOLDER | Garrett Medical Products | May 24, 1994 | SESE | | [K941384](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K941384.md) | TRAKEEZ | Ergomed, Inc. | Apr 19, 1994 | SESE | | [K940448](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K940448.md) | NETOH ENDOTRACHEAL TUBE HOLDER | Medical Accessory Services, Inc. | Feb 22, 1994 | SESE | | [K936094](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K936094.md) | PREPARE LOCK | Prepare, Inc. | Feb 3, 1994 | SESE | | [K935171](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K935171.md) | STABILTRACH | B&B Medical Technologies, Inc. | Dec 2, 1993 | SESE | | [K933420](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K933420.md) | BREATHING TUBE SUPPORT | Blake Medical, Inc. | Oct 13, 1993 | SESE | | [K933781](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K933781.md) | ANTI-DISCONNECTION MECHANISM | Hammer-Plane, Inc. | Sep 22, 1993 | SESE | | [K925386](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K925386.md) | ADHESIVE E.T. TAPE | B&B Medical Technologies, Inc. | Apr 19, 1993 | SESK | | [K924551](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K924551.md) | ENDO TRACHEA TUBE FIXATION | M. Imonti and Associates Inc., | Dec 8, 1992 | SESE | | [K921698](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K921698.md) | CN ENDOTRACHEAL TUBE HOLDER | N-C-N Products Co. | Sep 15, 1992 | SESE | | [K922657](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K922657.md) | AGA TRACH TIES | Aga Medical Products, Inc. | Jul 2, 1992 | SESE | | [K920691](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH/K920691.md) | THE LEWIS TUBE HOLDER | R. Lewis, Inc. | Mar 18, 1992 | SESE | ## Top Applicants - B&B Medical Technologies, Inc. — 8 clearances - Dale Medical Products, Inc. — 3 clearances - Respironics, Inc. — 3 clearances - Ackrad Laboratories — 2 clearances - Blake Medical, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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