Device, Fixation, Tracheal Tube
FDA product code CBH · Class I (low risk) · 21 CFR 868.5770 · Anesthesiology
47510(k) clearances
0PMA approvals
12recalls
Manufacturers
- B&B Medical Technologies, Inc. 8
- Respironics, Inc. 3
- Dale Medical Products, Inc. 3
- Ackrad Laboratories 2
- Rotek Corp. 2
- Blake Medical, Inc. 2
- Applied Medical Technology, Inc. 1
- Olympic Medical Corp. 1
- Aga Medical Products, Inc. 1
- R. Lewis, Inc. 1
- Salter Labs 1
- Nikomed U.S.A., Inc. 1
- Ventlab Corp. 1
- Auxiliary Care, Inc. 1
- Bioseal 1
- Mathew Medical Co. 1
- Kinetic Concepts, Inc. 1
- Laerdal California, Inc. 1
- Rnd Medical Products, Inc. 1
- Aircare Systems 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140097 | Amt Endotracheal Tube Bridle Retention SystemCBH · Traditional | Applied Medical Technology, Inc. | 09/24/2014SE |
| K964399 | Dale Endotracheal Tube Holder 270/280CBH · Traditional | Dale Medical Products, Inc. | 01/28/1997SE |
| K942529 | Hci Tube StabilizerCBH · Traditional | Health Care Contracts, Inc. | 06/14/1995SE |
| K951491 | Dale Tracheostomy Tube Holder with Trach Mask Attachment TabsCBH · Traditional | Dale Medical Products, Inc. | 04/24/1995SE |
| K950930 | Trache-TiteCBH · Traditional | The Varner Group, Inc. | 03/22/1995SE |
| K950318 | Flex BlueCBH · Traditional | King Systems Corp. | 02/13/1995SE |
| K942395 | Endotracheal Tube HolderCBH · Traditional | S.T.I. Medical Products Corp. | 06/30/1994SE |
| K934288 | Holde.T. Endotracheal Tube Stabilization BarCBH · Traditional | Neo-Tech, Inc. | 06/09/1994SE |
| K942016 | Trach Tie, Ventilator Tubing HolderCBH · Traditional | Garrett Medical Products | 05/24/1994SE |
| K941384 | TrakeezCBH · Traditional | Ergomed, Inc. | 04/19/1994SE |
| K940448 | Netoh Endotracheal Tube HolderCBH · Traditional | Medical Accessory Services, Inc. | 02/22/1994SE |
| K936094 | Prepare LockCBH · Traditional | Prepare, Inc. | 02/03/1994SE |
| K935171 | StabiltrachCBH · Traditional | B&B Medical Technologies, Inc. | 12/02/1993SE |
| K933420 | Breathing Tube SupportCBH · Traditional | Blake Medical, Inc. | 10/13/1993SE |
| K933781 | Anti-Disconnection MechanismCBH · Traditional | Hammer-Plane, Inc. | 09/22/1993SE |
| K925386 | Adhesive E.T. TapeCBH · Traditional | B&B Medical Technologies, Inc. | 04/19/1993SESK |
| K924551 | Endo Trachea Tube FixationCBH · Traditional | M. Imonti and Associates Inc., | 12/08/1992SE |
| K921698 | CN Endotracheal Tube HolderCBH · Traditional | N-C-N Products Co. | 09/15/1992SE |
| K922657 | Aga Trach TiesCBH · Traditional | Aga Medical Products, Inc. | 07/02/1992SE |
| K920691 | The Lewis Tube HolderCBH · Traditional | R. Lewis, Inc. | 03/18/1992SE |
| K912884 | E.T. Tape IICBH · Traditional | B&B Medical Technologies, Inc. | 07/31/1991SE |
| K905231 | Dale Ventilator Tubing Support for Trach. Vent.CBH · Traditional | Dale Medical Products, Inc. | 01/14/1991SE |
| K904974 | Trach CollarCBH · Traditional | Rotek Corp. | 01/11/1991SE |
| K903539 | Salter Labs Model #1015CBH · Traditional | Salter Labs | 12/17/1990SE |
| K902896 | 49-610 Niko-Nose Fixation TapeCBH · Traditional | Nikomed U.S.A., Inc. | 10/23/1990SE |
| K902604 | Blake Medical Breathing Tube SupportCBH · Traditional | Blake Medical, Inc. | 10/02/1990SE |
| K900912 | Baby E.T. Tape IICBH · Traditional | B&B Medical Technologies, Inc. | 08/03/1990SE |
| K902065 | E.T. Tape IICBH · Traditional | B&B Medical Technologies, Inc. | 07/23/1990SE |
| K900787 | Nasal E.T. TapeCBH · Traditional | B&B Medical Technologies, Inc. | 03/16/1990SE |
| K900236 | Et-Restraint Cat. # Er 4000CBH · Traditional | Ventlab Corp. | 02/02/1990SE |
| K882891 | A.C.I. Trach TieCBH · Traditional | Auxiliary Care, Inc. | 09/19/1988SE |
| K882079 | Respironic's Infant SecureeasyCBH · Traditional | Respironics, Inc. | 08/19/1988SE |
| K882694 | Fixation Device, Trach TubeCBH · Traditional | Bioseal | 08/15/1988SE |
| K872832 | Trach CollarCBH · Traditional | Rotek Corp. | 09/04/1987SE |
| K872277 | Trakefit Tracheostomy Tube HolderCBH · Traditional | Ackrad Laboratories | 07/21/1987SE |
| K871560 | Baby E.T. Tape(Tm)CBH · Traditional | B&B Medical Technologies, Inc. | 05/22/1987SE |
| K864526 | Endotracheal Tube HolderCBH · Traditional | Mathew Medical Co. | 05/21/1987SE |
| K862084 | E. T. Tape Endotracheal Tube HolderCBH · Traditional | B&B Medical Technologies, Inc. | 06/05/1986SE |
| K860845 | Respironics SecureasyCBH · Traditional | Respironics, Inc. | 03/13/1986SE |
| K851874 | Or Tube RestraintCBH · Traditional | Kinetic Concepts, Inc. | 08/08/1985SE |
| K843790 | Tracheal Tube Fixation DeviceCBH · Traditional | Laerdal California, Inc. | 03/11/1985SE |
| K830706 | E.T. Strap #6000CBH · Traditional | Rnd Medical Products, Inc. | 04/28/1983SE |
| K822794 | Respironics Endo Tube Control SysCBH · Traditional | Respironics, Inc. | 10/22/1982SE |
| K811185 | N-D0-SURECBH · Traditional | Ackrad Laboratories | 06/02/1981SE |
| K810737 | Endotracheal Tube HolderCBH · Traditional | Aircare Systems | 04/17/1981SE |
| K802601 | Endotracheal Tube HolderCBH · Traditional | Hudson Oxygen Therapy Sales Co. | 12/18/1980SE |
| K781695 | Lube-LokCBH · Traditional | Olympic Medical Corp. | 11/01/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1181-2025 Class II | AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | Hollister Incorporated | 12/23/2024Open, Classified |
| Z-1180-2025 Class II | AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | Hollister Incorporated | 12/23/2024Open, Classified |
| Z-1179-2025 Class II | AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | Hollister Incorporated | 12/23/2024Open, Classified |
| Z-1178-2025 Class II | AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | Hollister Incorporated | 12/23/2024Open, Classified |
| Z-0698-2025 Class II | HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF…Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder… | MEDLINE INDUSTRIES, LP - Northfield | 11/18/2024Open, Classified |
| Z-0697-2025 Class II | HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube…Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder… | MEDLINE INDUSTRIES, LP - Northfield | 11/18/2024Open, Classified |
| Z-0696-2025 Class II | HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF…Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder… | MEDLINE INDUSTRIES, LP - Northfield | 11/18/2024Open, Classified |
| Z-0695-2025 Class II | HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube…Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder… | MEDLINE INDUSTRIES, LP - Northfield | 11/18/2024Open, Classified |
| Z-1928-2017 Class II | Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock…ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to… | Dale Medical Products, Inc. | 03/24/2017Terminated |
| Z-1927-2017 Class II | Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock…ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to… | Dale Medical Products, Inc. | 03/24/2017Terminated |
| Z-0447-2008 | Dale 242 Blue (Neonate, Infants and Small Children) Tracheostomy Tube Holder, Product…Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to… | Dale Medical Products, Inc. | 09/27/2007Terminated |
| Z-0446-2008 | Dale 240 Blue (Adults) Tracheostomy Tube Holder, Product Number: H84102401, Dale Medical…Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to… | Dale Medical Products, Inc. | 09/27/2007Terminated |