FDA product code DRM: Compressor, Cardiac, External
DRM is the FDA product code for compressor, cardiac, external. It is a Class II device, regulated under 21 CFR 870.5200 and reviewed by the Cardiovascular panel. FDA has cleared 45 510(k) submissions under DRM, 1 in the last five years, from 24 different applicants. The average 510(k) review took 113 days (median 84). FDA has posted 12 recalls for DRM devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Compressor, Cardiac, External |
| Device class | Class II |
| Regulation | 21 CFR 870.5200 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for DRM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 84 |
| 2021 | 1 | 195 |
| 2023 | 1 | 269 |
Compare with all 510(k) review times · Search every DRM clearance
Top DRM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Michigan Instruments, Inc. | 6 | 2008-02-14 |
| Jolife AB | 5 | 2018-02-08 |
| Revivant Corp. | 4 | 2004-03-11 |
| Pneupac , Ltd. | 4 | 1980-02-05 |
| Zoll Circulation | 3 | 2012-03-15 |
19 more applicants have DRM clearances. See the full list in Caduvo.
Most recent DRM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221700 | Zoll Circulation, Inc. | AutoPulse NXT Resuscitation System | 2023-03-09 | 269 |
| K211289 | Defibtech, LLC | RMU-2000 Automated Chest Compression System | 2021-11-09 | 195 |
| K173553 | Jolife AB | LUCAS 3 Chest Compression System | 2018-02-08 | 84 |
| K161768 | Jolife AB | LUCAS 3 Chest Compression System | 2016-11-09 | 135 |
| K153628 | Resuscitation International, LLC | ROSC-U Mini Chest Compressor (RMCC) | 2016-01-30 | 43 |
Recalls for DRM devices
12 product recalls in 12 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2026-04-13.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code DRM?
DRM is the FDA product code for compressor, cardiac, external. It is a Class II device, regulated under 21 CFR 870.5200 and reviewed by the Cardiovascular panel.
What device class is DRM?
Class II, regulation 21 CFR 870.5200. Typical premarket route: 510(k).
How long does a 510(k) take for product code DRM?
Across 45 cleared submissions the average was 113 days from receipt to decision (median 84).
Which companies have the most DRM clearances?
Michigan Instruments, Inc. (6); Jolife AB (5); Revivant Corp. (4); Pneupac , Ltd. (4); Zoll Circulation (3).
Have DRM devices been recalled?
Yes: 12 product recalls across 12 recall events; the most recent began 2026-04-13.
Next steps
- Run an FDA pathway report with predicate devices for product code DRM
- Run a recall and safety report across every DRM manufacturer
- Watch product code DRM 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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