BTAClass II
Pump, Portable, Aspiration (Manual Or Powered)
21 CFR 878.4780 / General, Plastic Surgery
BTA is the FDA product code for Pump, Portable, Aspiration (Manual Or Powered), a class II device type, regulated under 21 CFR 878.4780. As of , FDA records hold 159 510(k) clearances under this code, the most recent dated , and 21 recalls.
Classification record
- Product code
- BTA
- Device name
- Pump, Portable, Aspiration (Manual Or Powered)
- Regulation
- 21 CFR 878.4780
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 159
- Ingested recalls
- 21
Clearances, product code BTA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1981 | 4 |
| 1982 | 3 |
| 1983 | 5 |
| 1984 | 8 |
| 1985 | 6 |
| 1986 | 5 |
| 1987 | 4 |
| 1988 | 2 |
| 1989 | 1 |
| 1991 | 1 |
| 1992 | 3 |
| 1993 | 5 |
| 1994 | 10 |
| 1995 | 15 |
| 1996 | 1 |
| 1997 | 6 |
| 1998 | 6 |
| 1999 | 5 |
| 2001 | 1 |
| 2002 | 3 |
| 2003 | 1 |
| 2004 | 5 |
| 2005 | 4 |
| 2006 | 4 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 2 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 3 |
| 2014 | 3 |
| 2016 | 3 |
| 2017 | 1 |
| 2018 | 4 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 4 |
| 2024 | 5 |
| 2025 | 6 |
| 2026 | 6 |
Applicants with the most clearances
Product code BTA| Applicant | Clearances |
|---|---|
| Medela AG | 10 |
| Aeros Instruments, Inc. | 5 |
| Egnell, Inc. | 5 |
| Thomas Industries | 5 |
| ZOLL Medical Corporation | 4 |
| Sscor | 4 |
| Advanced Cytometrix, Inc. | 3 |
| Precision Medical, Inc. | 3 |
| Shenzhen Desida Technology Co., Ltd. | 3 |
| Shenzhen Kingboom Technology Co., Ltd | 3 |
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.