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 |
|---|---|---|---|
| 00848530105860 | Tracheostomy and Suction Accessory | Sunset Healthcare Solutions, Inc. | 2025-06-03 |
| 00848530105853 | Tracheostomy and Suction Accessory | Sunset Healthcare Solutions, Inc. | 2025-06-03 |
| 00848530105846 | Tracheostomy and Suction Accessory | Sunset Healthcare Solutions, Inc. | 2025-06-03 |
| 00848530105839 | Tracheostomy and Suction Accessory | Sunset Healthcare Solutions, Inc. | 2025-06-03 |
| 00610075095834 | AnchorFast SlimFit | HOLLISTER INCORPORATED | 2024-11-05 |
| 00610075095766 | AnchorFast | HOLLISTER INCORPORATED | 2024-10-03 |
| 00610075095780 | AnchorFast Guard | HOLLISTER INCORPORATED | 2024-09-03 |
| 00610075095810 | AnchorFast Guard Select | HOLLISTER INCORPORATED | 2024-09-03 |
| 00848530103552 | Two Piece Tracheostomy Tie Pediatric 2cm x 35.5cm (14in) | Sunset Healthcare Solutions, Inc. | 2024-03-20 |
| 00848530103569 | Two Piece Tracheostomy Tie Pediatric 2cm x 45.5cm (18in) | Sunset Healthcare Solutions, Inc. | 2024-03-20 |
| 00848530103545 | Two Piece Tracheostomy Tie Pediatric 2cm x 25.5cm (10in) | Sunset Healthcare Solutions, Inc. | 2024-03-20 |
| 00848530103538 | Two Piece Tracheostomy Tie Adult 2.5cm x 51cm (20in) | Sunset Healthcare Solutions, Inc. | 2024-03-20 |
| 00848530103521 | One Piece Tracheostomy Tie Pediatric 2.5cm x 30cm (11.5in) | Sunset Healthcare Solutions, Inc. | 2024-03-20 |
| 00848530103514 | One Piece Tracheostomy Tie Adult 2.5cm x 43cm (17in) | Sunset Healthcare Solutions, Inc. | 2024-03-20 |
| 00610075186518 | AnchorFast Guard | HOLLISTER INCORPORATED | 2022-12-01 |
| 00610075097883 | AnchorFast | HOLLISTER INCORPORATED | 2022-12-01 |
| 00610075129386 | AnchorFast | HOLLISTER INCORPORATED | 2022-12-01 |
| 00610075067671 | AnchorFast Guard Select | HOLLISTER INCORPORATED | 2022-12-01 |
| 00610075066988 | AnchorFast SlimFit | HOLLISTER INCORPORATED | 2022-12-01 |
| 00840117312333 | Resp-O2 Breathable-Foam Trach Tube Holder, 1 PC, Neck 11-17"/28-43 cm | Dynarex Corporation | 2022-05-14 |
| 00840117319257 | Resp-O2 Comfort-Foam Trach Tube Holder, 2PC, Maximum Neck Size 9"/23 cm | Dynarex Corporation | 2022-05-14 |
| 00840117319264 | Resp-O2 Comfort-Foam Trach Tube Holder, 2 PC, Maximum Neck Size 18"/46 cm | Dynarex Corporation | 2022-05-14 |
| 00840117319271 | Resp-O2 Comfort-Foam Trach Tube Holder, 2 PC, Maximum Neck Size 19.5"/50 cm | Dynarex Corporation | 2022-05-14 |
| 00840117312326 | Resp-O2 Breathable-Foam Trach Tube Holder, 1PC, Neck 9-14"/23-35 cm | Dynarex Corporation | 2022-05-14 |
| 00840117319233 | Resp-O2 Comfort-Foam Trach Tube Holder, 1PC, Neck 9"-14"/23-35 cm | Dynarex Corporation | 2022-05-11 |
| 00840117319240 | Resp-O2 Comfort-Foam Trach Tube Holder, 1 PC, Neck 13"-19"/ 33-48 cm | Dynarex Corporation | 2022-05-11 |
| 00848530062248 | Tracheostomy Tube Neckband 2-Piece with Fastener Tabs - Pediatric | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530062231 | Tracheostomy Tube Neckband 2-Piece with Fastener Tabs - Adult | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530062200 | Tracheostomy Tube Neckband with Fastener Tabs - Pediatric | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530062194 | Tracheostomy Tube Neckband with Fastener Tabs - Adult | Sunset Healthcare Solutions, Inc. | 2018-07-31 |