FDA product code DPS: Electrocardiograph
DPS is the FDA product code for electrocardiograph. It is a Class II device, regulated under 21 CFR 870.2340 and reviewed by the Cardiovascular panel. FDA has cleared 576 510(k) submissions under DPS, 32 in the last five years, from 272 different applicants. The average 510(k) review took 136 days (median 105); 242 days on average over the last three years. FDA has posted 98 recalls for DPS devices, 19 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Electrocardiograph |
| Device class | Class II |
| Regulation | 21 CFR 870.2340 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DPS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 209 |
| 2018 | 14 | 211 |
| 2019 | 3 | 193 |
| 2020 | 6 | 268 |
| 2021 | 5 | 226 |
| 2022 | 6 | 206 |
| 2023 | 10 | 204 |
| 2024 | 8 | 257 |
| 2025 | 6 | 182 |
| 2026 | 2 | 286 |
Compare with all 510(k) review times · Search every DPS clearance
Top DPS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mortara Instrument, Inc. | 21 | 2016-01-06 |
| Nihon Kohden America, Inc. | 21 | 2007-08-30 |
| Edan Instruments, Inc. | 19 | 2026-07-02 |
| Quinton, Inc. | 17 | 2000-08-09 |
| Hewlett-Packard Co. | 14 | 1998-03-18 |
267 more applicants have DPS clearances. See the full list in Caduvo.
Most recent DPS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252463 | Edan Instruments, Inc. | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | 2026-07-02 | 330 |
| K251670 | Ge Medical Systems Information Technologies, Inc. | MAC 7 Resting ECG Analysis System | 2026-01-26 | 241 |
| K252361 | Accurkardia, Inc. | AccurECG Analysis System (v2.0) | 2025-12-22 | 146 |
| K252474 | Withings | Withings BeamO (SCT02) | 2025-11-10 | 96 |
| K250569 | Philips France Commercial | Cardiologs Holter Platform | 2025-08-06 | 161 |
Recalls for DPS devices
98 product recalls in 34 recall events; 19 initiated in the last five years and 28 still open. Most recent: 2026-07-20.
| Year | Recalls |
|---|---|
| 2019 | 9 |
| 2020 | 13 |
| 2021 | 5 |
| 2022 | 2 |
| 2023 | 3 |
| 2024 | 6 |
| 2025 | 4 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code DPS?
DPS is the FDA product code for electrocardiograph. It is a Class II device, regulated under 21 CFR 870.2340 and reviewed by the Cardiovascular panel.
What device class is DPS?
Class II, regulation 21 CFR 870.2340. Typical premarket route: 510(k).
How long does a 510(k) take for product code DPS?
Across 576 cleared submissions the average was 136 days from receipt to decision (median 105).
Which companies have the most DPS clearances?
Mortara Instrument, Inc. (21); Nihon Kohden America, Inc. (21); Edan Instruments, Inc. (19); Quinton, Inc. (17); Hewlett-Packard Co. (14).
Have DPS devices been recalled?
Yes: 98 product recalls across 34 recall events; the most recent began 2026-07-20.
Next steps
- Run an FDA pathway report with predicate devices for product code DPS
- Run a recall and safety report across every DPS manufacturer
- Watch product code DPS 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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