BSOClass II
Catheter, Conduction, Anesthetic
21 CFR 868.5120 / Anesthesiology
BSO is the FDA product code for Catheter, Conduction, Anesthetic, a class II device type, regulated under 21 CFR 868.5120. As of , FDA records hold 75 510(k) clearances under this code, the most recent dated , and 119 recalls.
Classification record
- Product code
- BSO
- Device name
- Catheter, Conduction, Anesthetic
- Regulation
- 21 CFR 868.5120
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 75
- Ingested recalls
- 119
Clearances, product code BSO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 2 |
| 1985 | 3 |
| 1986 | 2 |
| 1989 | 2 |
| 1990 | 3 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 2 |
| 2000 | 3 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 4 |
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 3 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 4 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 5 |
| 2017 | 3 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 2 |
| 2023 | 2 |
| 2025 | 1 |
Applicants with the most clearances
Product code BSO| Applicant | Clearances |
|---|---|
| Abbott Medical | 6 |
| B.Braun Medical, Inc. | 6 |
| Epimed International, Inc. | 4 |
| Halyard Health | 4 |
| Baxter Healthcare Corporation | 3 |
| Pajunk GmbH Medizintechnologie | 3 |
| Parke-Davis Co. | 3 |
| Axiom Medical, Inc. | 2 |
| Busse Hospital Disposables | 2 |
| Ebi, LLC | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
