FDA product code DRN: Device, Counter-Pulsating, External
DRN is the FDA product code for device, counter-pulsating, external. It is a Class II device, regulated under 21 CFR 870.5225 and reviewed by the Cardiovascular panel. FDA has cleared 34 510(k) submissions under DRN, 1 in the last five years, from 21 different applicants. The average 510(k) review took 165 days (median 106); 285 days on average over the last three years. FDA has posted 1 recall for DRN devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Counter-Pulsating, External |
| Device class | Class II |
| Regulation | 21 CFR 870.5225 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for DRN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 198 |
| 2019 | 1 | 176 |
| 2020 | 2 | 204 |
| 2025 | 1 | 285 |
Compare with all 510(k) review times · Search every DRN clearance
Top DRN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cardiomedics, Inc. | 5 | 2005-03-31 |
| Circulator Boot Corp. | 4 | 2009-05-07 |
| Vasomedical, Inc. | 3 | 2004-03-01 |
| Vamed Medical Instrument Co., Ltd. | 2 | 2020-08-28 |
| Living Data Technologies Corporation | 2 | 2003-12-19 |
16 more applicants have DRN clearances. See the full list in Caduvo.
Most recent DRN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250756 | Pression, Inc. | Pression Wave PRO External Counter-Pulsation System | 2025-12-22 | 285 |
| K202108 | Vamed Medical Instrument Co., Ltd. | External Counterpulsation System, Soulaire | 2020-08-28 | 29 |
| K191955 | Omay(Guangzhou)Med Technologies Co., Ltd. | Enhanced External Counter Pulsation Device Plus Omay-A | 2020-08-05 | 380 |
| K190683 | Vamed Medical Instrument Co., Ltd. | External Counterpulsation System | 2019-09-10 | 176 |
| K173483 | Xtreem Pulse, LLC | Pure Flow External Counter-Pulsation Device | 2018-05-30 | 198 |
Recalls for DRN devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-04-09.
Frequently asked questions
What is FDA product code DRN?
DRN is the FDA product code for device, counter-pulsating, external. It is a Class II device, regulated under 21 CFR 870.5225 and reviewed by the Cardiovascular panel.
What device class is DRN?
Class II, regulation 21 CFR 870.5225. Typical premarket route: 510(k).
How long does a 510(k) take for product code DRN?
Across 34 cleared submissions the average was 165 days from receipt to decision (median 106).
Which companies have the most DRN clearances?
Cardiomedics, Inc. (5); Circulator Boot Corp. (4); Vasomedical, Inc. (3); Vamed Medical Instrument Co., Ltd. (2); Living Data Technologies Corporation (2).
Have DRN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2009-04-09.
Next steps
- Run an FDA pathway report with predicate devices for product code DRN
- Run a recall and safety report across every DRN manufacturer
- Watch product code DRN 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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