CBH · Device, Fixation, Tracheal Tube
Anesthesiology · 21 CFR 868.5770 · Class 1
Overview
| Product Code | CBH |
|---|---|
| Device Name | Device, Fixation, Tracheal Tube |
| Regulation | 21 CFR 868.5770 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
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 | AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM | Applied Medical Technology, Inc. | Sep 24, 2014 | SESE |
| K964399 | DALE ENDOTRACHEAL TUBE HOLDER 270/280 | Dale Medical Products, Inc. | Jan 28, 1997 | SESE |
| K942529 | HCI TUBE STABILIZER | Health Care Contracts, Inc. | Jun 14, 1995 | SESE |
| K951491 | DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS | Dale Medical Products, Inc. | Apr 24, 1995 | SESE |
| K950930 | TRACHE-TITE | The Varner Group, Inc. | Mar 22, 1995 | SESE |
| K950318 | FLEX BLUE | King Systems Corp. | Feb 13, 1995 | SESE |
| K942395 | ENDOTRACHEAL TUBE HOLDER | S.T.I. Medical Products Corp. | Jun 30, 1994 | SESE |
| K934288 | HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR | Neo-Tech, Inc. | Jun 9, 1994 | SESE |
| K942016 | TRACH TIE, VENTILATOR TUBING HOLDER | Garrett Medical Products | May 24, 1994 | SESE |
| K941384 | TRAKEEZ | Ergomed, Inc. | Apr 19, 1994 | SESE |
| K940448 | NETOH ENDOTRACHEAL TUBE HOLDER | Medical Accessory Services, Inc. | Feb 22, 1994 | SESE |
| K936094 | PREPARE LOCK | Prepare, Inc. | Feb 3, 1994 | SESE |
| K935171 | STABILTRACH | B&B Medical Technologies, Inc. | Dec 2, 1993 | SESE |
| K933420 | BREATHING TUBE SUPPORT | Blake Medical, Inc. | Oct 13, 1993 | SESE |
| K933781 | ANTI-DISCONNECTION MECHANISM | Hammer-Plane, Inc. | Sep 22, 1993 | SESE |
| K925386 | ADHESIVE E.T. TAPE | B&B Medical Technologies, Inc. | Apr 19, 1993 | SESK |
| K924551 | ENDO TRACHEA TUBE FIXATION | M. Imonti and Associates Inc., | Dec 8, 1992 | SESE |
| K921698 | CN ENDOTRACHEAL TUBE HOLDER | N-C-N Products Co. | Sep 15, 1992 | SESE |
| K922657 | AGA TRACH TIES | Aga Medical Products, Inc. | Jul 2, 1992 | SESE |
| K920691 | 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
