DRSClass II
Transducer, Blood-Pressure, Extravascular
21 CFR 870.2850 / Cardiovascular
DRS is the FDA product code for Transducer, Blood-Pressure, Extravascular, a class II device type, regulated under 21 CFR 870.2850. As of , FDA records hold 148 510(k) clearances under this code, the most recent dated , and 236 recalls.
Classification record
- Product code
- DRS
- Device name
- Transducer, Blood-Pressure, Extravascular
- Regulation
- 21 CFR 870.2850
- 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
- 149
- Ingested recalls
- 236
Clearances, product code DRS
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1978 | 5 |
| 1979 | 4 |
| 1980 | 9 |
| 1981 | 16 |
| 1982 | 19 |
| 1983 | 12 |
| 1984 | 10 |
| 1985 | 13 |
| 1986 | 6 |
| 1987 | 5 |
| 1988 | 4 |
| 1989 | 2 |
| 1990 | 5 |
| 1991 | 2 |
| 1992 | 2 |
| 1993 | 2 |
| 1995 | 1 |
| 1996 | 2 |
| 1998 | 2 |
| 1999 | 1 |
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 1 |
| 2009 | 2 |
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 3 |
| 2017 | 2 |
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code DRS| Applicant | Clearances |
|---|---|
| Sorensen Research | 7 |
| Transamerica Delaval, Inc. | 6 |
| Hewlett-Packard Co. | 5 |
| Bentley Laboratories, Inc. | 4 |
| Bio-Med Corp. | 4 |
| Gould, Inc. | 4 |
| Graphic Controls Corp. | 4 |
| Abbott Medical | 4 |
| Mirador Biomedical, Inc. | 4 |
| Norton Performance Plastics Corp. | 4 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Medical
- Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.
- Amphenol Medical Technologies (Dongguan) Co., Ltd.
- Argon Medical Devices, Inc
- Becton Dickinson & Co
- Bioptimal International Pte. Ltd.
- Bioxin Medical Co., Ltd
- Bmmedical
- C.R. Bard Inc
- Centurion Medical Products, LP
- Convertors de Mexico S. de R.L. de C.V
- Cook Medical LLC
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
