FDA product code DSI: Detector And Alarm, Arrhythmia
DSI is the FDA product code for detector and alarm, arrhythmia. It is a Class II device, regulated under 21 CFR 870.1025 and reviewed by the Cardiovascular panel. FDA has cleared 398 510(k) submissions under DSI, 5 in the last five years, from 143 different applicants. The average 510(k) review took 150 days (median 117); 302 days on average over the last three years. FDA has posted 82 recalls for DSI devices, 25 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Detector And Alarm, Arrhythmia |
| Device class | Class II |
| Regulation | 21 CFR 870.1025 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for DSI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 148 |
| 2019 | 3 | 240 |
| 2020 | 2 | 167 |
| 2023 | 2 | 184 |
| 2024 | 1 | 281 |
| 2025 | 1 | 172 |
| 2026 | 1 | 452 |
Compare with all 510(k) review times · Search every DSI clearance
Top DSI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 27 | 2004-03-23 |
| Fukuda Denshi USA, Inc. | 19 | 2002-02-06 |
| Nihon Kohden America, Inc. | 18 | 2001-02-08 |
| Hewlett-Packard Co. | 17 | 1999-11-08 |
| Oxford Medilog, Inc. | 14 | 1989-04-20 |
138 more applicants have DSI clearances. See the full list in Caduvo.
Most recent DSI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243349 | Boston Scientific Cardiac Diagnostic Technologies, Inc. | BodyGuardian Remote Monitoring System (BGRMS v3.0) | 2026-01-23 | 452 |
| K250356 | Infobionic, Inc. | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | 2025-07-29 | 172 |
| K240177 | iRhythm Technologies, Inc. | Zio AT® device (A100A1001) | 2024-10-30 | 281 |
| K230265 | Infobionic, Inc. | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | 2023-10-06 | 248 |
| K231276 | Smartcardia SA | SmartCardia 7L Platform | 2023-08-30 | 120 |
Recalls for DSI devices
82 product recalls in 51 recall events; 25 initiated in the last five years and 31 still open. Most recent: 2026-03-26.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 5 |
| 2019 | 9 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 3 |
| 2025 | 19 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code DSI?
DSI is the FDA product code for detector and alarm, arrhythmia. It is a Class II device, regulated under 21 CFR 870.1025 and reviewed by the Cardiovascular panel.
What device class is DSI?
Class II, regulation 21 CFR 870.1025. Typical premarket route: 510(k).
How long does a 510(k) take for product code DSI?
Across 398 cleared submissions the average was 150 days from receipt to decision (median 117).
Which companies have the most DSI clearances?
Siemens Medical Solutions USA, Inc. (27); Fukuda Denshi USA, Inc. (19); Nihon Kohden America, Inc. (18); Hewlett-Packard Co. (17); Oxford Medilog, Inc. (14).
Have DSI devices been recalled?
Yes: 82 product recalls across 51 recall events; the most recent began 2026-03-26.
Next steps
- Run an FDA pathway report with predicate devices for product code DSI
- Run a recall and safety report across every DSI manufacturer
- Watch product code DSI 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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