Product code CBH
- Device name
- Device, Fixation, Tracheal Tube
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5770
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140097 | AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM | Applied Medical Technology, Inc. | 2014-09-24 |
| K964399 | DALE ENDOTRACHEAL TUBE HOLDER 270/280 | Dale Medical Products, Inc. | 1997-01-28 |
| K942529 | HCI TUBE STABILIZER | Health Care Contracts, Inc. | 1995-06-14 |
| K951491 | DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS | Dale Medical Products, Inc. | 1995-04-24 |
| K950930 | TRACHE-TITE | The Varner Group, Inc. | 1995-03-22 |
| K950318 | FLEX BLUE | King Systems Corp. | 1995-02-13 |
| K942395 | ENDOTRACHEAL TUBE HOLDER | S.T.I. Medical Products Corp. | 1994-06-30 |
| K934288 | HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR | Neo-Tech, Inc. | 1994-06-09 |
| K942016 | TRACH TIE, VENTILATOR TUBING HOLDER | Garrett Medical Products | 1994-05-24 |
| K941384 | TRAKEEZ | Ergomed, Inc. | 1994-04-19 |
| K940448 | NETOH ENDOTRACHEAL TUBE HOLDER | Medical Accessory Services, Inc. | 1994-02-22 |
| K936094 | PREPARE LOCK | Prepare, Inc. | 1994-02-03 |
| K935171 | STABILTRACH | B&B Medical Technologies, Inc. | 1993-12-02 |
| K933420 | BREATHING TUBE SUPPORT | Blake Medical, Inc. | 1993-10-13 |
| K933781 | ANTI-DISCONNECTION MECHANISM | Hammer-Plane, Inc. | 1993-09-22 |
| K925386 | ADHESIVE E.T. TAPE | B&B Medical Technologies, Inc. | 1993-04-19 |
| K924551 | ENDO TRACHEA TUBE FIXATION | M. Imonti and Associates Inc., | 1992-12-08 |
| K921698 | CN ENDOTRACHEAL TUBE HOLDER | N-C-N Products Co. | 1992-09-15 |
| K922657 | AGA TRACH TIES | Aga Medical Products, Inc. | 1992-07-02 |
| K920691 | THE LEWIS TUBE HOLDER | R. Lewis, Inc. | 1992-03-18 |
| K912884 | E.T. TAPE II | B&B Medical Technologies, Inc. | 1991-07-31 |
| K905231 | DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT. | Dale Medical Products, Inc. | 1991-01-14 |
| K904974 | TRACH COLLAR | Rotek Corp. | 1991-01-11 |
| K903539 | SALTER LABS MODEL #1015 | Salter Labs | 1990-12-17 |
| K902896 | 49-610 NIKO-NOSE FIXATION TAPE | Nikomed U.S.A., Inc. | 1990-10-23 |
| K902604 | BLAKE MEDICAL BREATHING TUBE SUPPORT | Blake Medical, Inc. | 1990-10-02 |
| K900912 | BABY E.T. TAPE II | B&B Medical Technologies, Inc. | 1990-08-03 |
| K902065 | E.T. TAPE II | B&B Medical Technologies, Inc. | 1990-07-23 |
| K900787 | NASAL E.T. TAPE | B&B Medical Technologies, Inc. | 1990-03-16 |
| K900236 | ET-RESTRAINT CAT. # ER 4000 | Ventlab Corp. | 1990-02-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810003756015 | KENOREX | KENTRON HEALTHCARE, INC. | 2026-06-01 |
| 08904428744947 | OSSEOUS- NeckFit Tube Holder | EON MEDITECH PRIVATE LIMITED | 2026-03-13 |
| 10192253044591 | Argyle | Cardinal Health 200, LLC | 2025-08-26 |
| 10197344103614 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-08-01 |
| 10197344103607 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-08-01 |
| 10197344103621 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-08-01 |
| 10197344103652 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-08-01 |
| 10197344103638 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-08-01 |
| 10197344103645 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-08-01 |
| 10195327306847 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-12-25 |
| 10190676001856 | POSEY | POSEY PRODUCTS, LLC | 2022-10-05 |
| 10190676002181 | POSEY | POSEY PRODUCTS, LLC | 2022-10-05 |
| 10190676002198 | POSEY | POSEY PRODUCTS, LLC | 2022-10-05 |
| 10190676002204 | POSEY | POSEY PRODUCTS, LLC | 2022-10-05 |
| 10190676002211 | POSEY | POSEY PRODUCTS, LLC | 2022-10-05 |
| 10190676002228 | POSEY | POSEY PRODUCTS, LLC | 2022-10-05 |
| 10190676002235 | POSEY | POSEY PRODUCTS, LLC | 2022-10-05 |
| 10190676002242 | POSEY | POSEY PRODUCTS, LLC | 2022-10-05 |
| 10080196804214 | Medline | MEDLINE INDUSTRIES, INC. | 2021-09-14 |
| 10193489005301 | Medline | MEDLINE INDUSTRIES, INC. | 2021-07-13 |
| 10193489005332 | Medline | MEDLINE INDUSTRIES, INC. | 2021-07-13 |
| H84102731 | Dale Adhesive Base | Dale Medical Products, Inc. | 2018-08-29 |
| H84102801 | Dale Endotracheal Tube Holder | Dale Medical Products, Inc. | 2018-08-29 |
| H84102001 | Dale 200 One Piece Holder | Dale Medical Products, Inc. | 2018-08-27 |
| H84102441 | Dale 244 Blue | Dale Medical Products, Inc. | 2018-08-27 |
| H84102421 | Dale PediPrints | Dale Medical Products, Inc. | 2018-08-27 |
| H84102411 | Dale PediPrints | Dale Medical Products, Inc. | 2018-08-27 |
| H84102401 | Dale 240 Blue | Dale Medical Products, Inc. | 2018-08-27 |
| 10607411001144 | N/A | SALTER LABS | 2016-11-30 |
| 10607411001151 | N/A | SALTER LABS | 2016-11-30 |