FDA product code CBH: Device, Fixation, Tracheal Tube
CBH is the FDA product code for device, fixation, tracheal tube. It is a Class I device, regulated under 21 CFR 868.5770 and reviewed by the Anesthesiology panel. FDA has cleared 47 510(k) submissions under CBH, from 33 different applicants. The average 510(k) review took 79 days (median 49). FDA has posted 12 recalls for CBH devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Fixation, Tracheal Tube |
| Device class | Class I |
| Regulation | 21 CFR 868.5770 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CBH clearance
Top CBH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| B&B Medical Technologies, Inc. | 8 | 1993-12-02 |
| Dale Medical Products, Inc. | 3 | 1997-01-28 |
| Respironics, Inc. | 3 | 1988-08-19 |
| Blake Medical, Inc. | 2 | 1993-10-13 |
| Rotek Corp. | 2 | 1991-01-11 |
28 more applicants have CBH clearances. See the full list in Caduvo.
Most recent CBH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140097 | Applied Medical Technology, Inc. | AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM | 2014-09-24 | 253 |
| K964399 | Dale Medical Products, Inc. | DALE ENDOTRACHEAL TUBE HOLDER 270/280 | 1997-01-28 | 85 |
| K942529 | Health Care Contracts, Inc. | HCI TUBE STABILIZER | 1995-06-14 | 383 |
| K951491 | Dale Medical Products, Inc. | DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS | 1995-04-24 | 24 |
| K950930 | The Varner Group, Inc. | TRACHE-TITE | 1995-03-22 | 21 |
Recalls for CBH devices
12 product recalls in 4 recall events; 8 initiated in the last five years and 8 still open. Most recent: 2024-12-23.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2024 | 8 |
Frequently asked questions
What is FDA product code CBH?
CBH is the FDA product code for device, fixation, tracheal tube. It is a Class I device, regulated under 21 CFR 868.5770 and reviewed by the Anesthesiology panel.
What device class is CBH?
Class I, regulation 21 CFR 868.5770. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CBH?
Across 47 cleared submissions the average was 79 days from receipt to decision (median 49).
Which companies have the most CBH clearances?
B&B Medical Technologies, Inc. (8); Dale Medical Products, Inc. (3); Respironics, Inc. (3); Blake Medical, Inc. (2); Rotek Corp. (2).
Have CBH devices been recalled?
Yes: 12 product recalls across 4 recall events; the most recent began 2024-12-23.
Next steps
- Run an FDA pathway report with predicate devices for product code CBH
- Run a recall and safety report across every CBH manufacturer
- Watch product code CBH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Anesthesiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times