DPWClass II
Flowmeter, Blood, Cardiovascular
21 CFR 870.2100 / Cardiovascular
DPW is the FDA product code for Flowmeter, Blood, Cardiovascular, a class II device type, regulated under 21 CFR 870.2100. As of , FDA records hold 138 510(k) clearances under this code, the most recent dated , and 35 recalls.
Classification record
- Product code
- DPW
- Device name
- Flowmeter, Blood, Cardiovascular
- Regulation
- 21 CFR 870.2100
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 138
- Ingested recalls
- 35
Clearances, product code DPW
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 1 |
| 1978 | 1 |
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 6 |
| 1982 | 4 |
| 1985 | 5 |
| 1986 | 7 |
| 1987 | 4 |
| 1988 | 5 |
| 1989 | 2 |
| 1990 | 9 |
| 1991 | 8 |
| 1992 | 3 |
| 1993 | 8 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 1998 | 7 |
| 1999 | 4 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 4 |
| 2003 | 6 |
| 2004 | 5 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2010 | 2 |
| 2011 | 4 |
| 2012 | 1 |
| 2013 | 2 |
| 2015 | 3 |
| 2016 | 1 |
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 3 |
| 2026 | 2 |
Applicants with the most clearances
Product code DPW| Applicant | Clearances |
|---|---|
| Koven Technology, Inc. | 7 |
| Deltex Medical Limited | 6 |
| Perimed AB | 6 |
| Koven and Assoc., Inc. | 5 |
| Transonic Systems Inc | 5 |
| Cardio Metrics, Inc. | 4 |
| Flosonics Medical | 4 |
| Remington Medical | 4 |
| Cardiosonix, Ltd. | 3 |
| Tsi, Inc. | 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.