BTOClass II
Tube, Tracheostomy (W/Wo Connector)
21 CFR 868.5800 / Anesthesiology
BTO is the FDA product code for Tube, Tracheostomy (W/Wo Connector), a class II device type, regulated under 21 CFR 868.5800. As of , FDA records hold 128 510(k) clearances under this code, the most recent dated , and 73 recalls.
Classification record
- Product code
- BTO
- Device name
- Tube, Tracheostomy (W/Wo Connector)
- Regulation
- 21 CFR 868.5800
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 129
- Ingested recalls
- 73
Clearances, product code BTO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 2 |
| 1978 | 1 |
| 1979 | 4 |
| 1980 | 3 |
| 1981 | 7 |
| 1982 | 3 |
| 1983 | 5 |
| 1984 | 12 |
| 1985 | 9 |
| 1986 | 9 |
| 1987 | 6 |
| 1988 | 8 |
| 1989 | 5 |
| 1990 | 9 |
| 1991 | 2 |
| 1992 | 7 |
| 1993 | 4 |
| 1995 | 4 |
| 1996 | 3 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2002 | 1 |
| 2003 | 3 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 1 |
| 2012 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code BTO| Applicant | Clearances |
|---|---|
| Shiley, Inc. | 13 |
| Bivona Medical Technologies | 6 |
| American Healthcare Corp. | 5 |
| Frederic J. Toye, M.D. | 5 |
| Abbott Medical | 5 |
| Hood Laboratories | 4 |
| Boston Medical Products, Inc. | 3 |
| Concord/Portex | 3 |
| Implant Technology, Inc. | 3 |
| Intl. Medical Devices, Ltd. | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Medical
- Aspen Surgical Products, Inc.
- BD Medical Development
- Biotronix Healthcare Industries Inc.
- Bmmedical
- Boston Medical Products, Inc.
- Burak Global IC ve Dis Tic Ltd Sti
- Cardinal Health (Kenmex Medical Specialties)
- CBR Enterprise Limited
- Cook Incorporated
- E. Benson Hood Laboratories, Inc.
- Engineered Medical Systems, LLC
FIRST ARTICLE / WEEKLY
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