DRGClass II
Transmitters And Receivers, Physiological Signal, Radiofrequency
21 CFR 870.2910 / Cardiovascular
DRG is the FDA product code for Transmitters And Receivers, Physiological Signal, Radiofrequency, a class II device type, regulated under 21 CFR 870.2910. As of , FDA records hold 192 510(k) clearances under this code, the most recent dated , and 12 recalls.
Classification record
- Product code
- DRG
- Device name
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- Regulation
- 21 CFR 870.2910
- 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
- 192
- Ingested recalls
- 12
Clearances, product code DRG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1979 | 3 |
| 1980 | 3 |
| 1981 | 4 |
| 1982 | 2 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 3 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1991 | 2 |
| 1992 | 1 |
| 1994 | 2 |
| 1995 | 4 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 3 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 3 |
| 2004 | 3 |
| 2005 | 6 |
| 2006 | 11 |
| 2007 | 6 |
| 2008 | 5 |
| 2009 | 13 |
| 2010 | 10 |
| 2011 | 9 |
| 2012 | 12 |
| 2013 | 13 |
| 2014 | 10 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 7 |
| 2018 | 6 |
| 2019 | 5 |
| 2020 | 6 |
| 2021 | 2 |
| 2022 | 6 |
| 2023 | 4 |
| 2024 | 3 |
| 2025 | 3 |
| 2026 | 2 |
Applicants with the most clearances
Product code DRG| Applicant | Clearances |
|---|---|
| VitalConnect, Inc. | 9 |
| Honeywell Hommed, LLC | 6 |
| American Telecare, Inc. | 5 |
| General Devices | 5 |
| Nihon Kohden America Inc | 5 |
| Bl Healthcare, Inc. | 4 |
| Health Hero Network, Inc. | 4 |
| LifeSignals, Inc. | 4 |
| Philips North America LLC | 4 |
| Carematix Inc. | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Medical
- Abbott Vascular
- Abbott Vascular Netherlands
- ActiGraph L.L.C.
- All Quality & Services, Inc.
- Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.
- Amphenol Medical Technologies (Dongguan) Co., Ltd.
- Athena GTX
- Avita (Wujiang) Co., Ltd
- Biobeat Technologies Ltd
- Biointellisense Inc.
- Boston Scientific Corporation
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.
