FDA product code DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency
DRG is the FDA product code for transmitters and receivers, physiological signal, radiofrequency. It is a Class II device, regulated under 21 CFR 870.2910 and reviewed by the Cardiovascular panel. FDA has cleared 192 510(k) submissions under DRG, 18 in the last five years, from 126 different applicants. The average 510(k) review took 127 days (median 100); 114 days on average over the last three years. FDA has posted 12 recalls for DRG devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device class | Class II |
| Regulation | 21 CFR 870.2910 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DRG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 146 |
| 2018 | 6 | 253 |
| 2019 | 5 | 109 |
| 2020 | 6 | 185 |
| 2021 | 2 | 217 |
| 2022 | 6 | 294 |
| 2023 | 4 | 259 |
| 2024 | 3 | 136 |
| 2025 | 3 | 113 |
| 2026 | 2 | 92 |
Compare with all 510(k) review times · Search every DRG clearance
Top DRG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vitalconnect, Inc. | 9 | 2020-04-20 |
| Honeywell Hommed, LLC | 5 | 2016-06-03 |
| Nihon Kohden America, Inc. | 5 | 2007-06-29 |
| American Telecare, Inc. | 5 | 2003-08-19 |
| General Devices | 5 | 2002-01-18 |
121 more applicants have DRG clearances. See the full list in Caduvo.
Most recent DRG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261569 | Lifesignals, Inc. | UbiqVue 2AYe Cardiac System (UX2253) | 2026-07-09 | 58 |
| K252984 | Perin Health Devices, LLC | Perin Health System (PHD80060-2) | 2026-01-22 | 126 |
| K252440 | Ingeniars S.R.L. | EasyTeleMed (2.0.2) | 2025-10-02 | 59 |
| K250259 | The ScottCare Corporation | TeleRehab Aermos Cardiopulmonary Rehabilitation | 2025-06-04 | 127 |
| K243837 | Iorbit Digital Technologies Private Limited | iBSM | 2025-05-16 | 154 |
Recalls for DRG devices
12 product recalls in 11 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2026-07-20.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2024 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code DRG?
DRG is the FDA product code for transmitters and receivers, physiological signal, radiofrequency. It is a Class II device, regulated under 21 CFR 870.2910 and reviewed by the Cardiovascular panel.
What device class is DRG?
Class II, regulation 21 CFR 870.2910. Typical premarket route: 510(k).
How long does a 510(k) take for product code DRG?
Across 192 cleared submissions the average was 127 days from receipt to decision (median 100).
Which companies have the most DRG clearances?
Vitalconnect, Inc. (9); Honeywell Hommed, LLC (5); Nihon Kohden America, Inc. (5); American Telecare, Inc. (5); General Devices (5).
Have DRG devices been recalled?
Yes: 12 product recalls across 11 recall events; the most recent began 2026-07-20.
Next steps
- Run an FDA pathway report with predicate devices for product code DRG
- Run a recall and safety report across every DRG manufacturer
- Watch product code DRG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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