BWFClass II
Spirometer, Therapeutic (Incentive)
21 CFR 868.5690 / Anesthesiology
BWF is the FDA product code for Spirometer, Therapeutic (Incentive), a class II device type, regulated under 21 CFR 868.5690. As of , FDA records hold 108 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- BWF
- Device name
- Spirometer, Therapeutic (Incentive)
- Regulation
- 21 CFR 868.5690
- 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
- 108
- Ingested recalls
- 1
Clearances, product code BWF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 3 |
| 1978 | 9 |
| 1979 | 7 |
| 1980 | 4 |
| 1981 | 2 |
| 1982 | 5 |
| 1983 | 4 |
| 1984 | 4 |
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 5 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 2 |
| 1991 | 1 |
| 1992 | 1 |
| 1994 | 1 |
| 1995 | 4 |
| 1996 | 4 |
| 1997 | 2 |
| 1998 | 2 |
| 1999 | 5 |
| 2000 | 5 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 1 |
| 2016 | 3 |
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code BWF| Applicant | Clearances |
|---|---|
| Dhd Healthcare Corp. | 5 |
| Dhd Medical Products Div. Diemolding Corp. | 4 |
| Health Products, Inc. | 4 |
| Advanced Circulatory Systems, Inc. | 3 |
| Chesebrough-Pond'S U.S.A. Co. | 3 |
| Dhd Diemolding Healthcare Div. | 3 |
| Trudell Medical International | 3 |
| Airlife, Inc. | 2 |
| Besmed Health Business Corporation | 2 |
| D R Burton Healthcare, 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.