FDA product code DSH: Recorder, Magnetic Tape, Medical
DSH is the FDA product code for recorder, magnetic tape, medical. It is a Class II device, regulated under 21 CFR 870.2800 and reviewed by the Cardiovascular panel. FDA has cleared 195 510(k) submissions under DSH, 18 in the last five years, from 121 different applicants. The average 510(k) review took 125 days (median 83); 209 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Recorder, Magnetic Tape, Medical |
| Device class | Class II |
| Regulation | 21 CFR 870.2800 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DSH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 119 |
| 2018 | 3 | 270 |
| 2019 | 3 | 49 |
| 2020 | 4 | 129 |
| 2021 | 4 | 208 |
| 2022 | 4 | 388 |
| 2023 | 6 | 176 |
| 2024 | 2 | 226 |
| 2025 | 4 | 184 |
| 2026 | 2 | 218 |
Compare with all 510(k) review times · Search every DSH clearance
Top DSH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Del Mar Avionics | 15 | 1999-02-09 |
| Bardy Diagnostics, Inc. | 7 | 2023-11-22 |
| iRhythm Technologies, Inc. | 6 | 2025-08-15 |
| Oxford Medilog, Inc. | 6 | 1989-03-15 |
| Cardiocomm Solutions, Inc. | 4 | 2011-10-07 |
116 more applicants have DSH clearances. See the full list in Caduvo.
Most recent DSH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260157 | LifeLens Technologies, Inc. | LifeLens Physiological Monitor | 2026-07-09 | 170 |
| K252389 | Smwmed, Inc. | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | 2026-04-23 | 266 |
| K253293 | Vitalograph , Ltd. | VitaloJAK Clinic (Model 7100) | 2025-12-03 | 65 |
| K243650 | iRhythm Technologies, Inc. | Zio® monitor (DFG0001) | 2025-08-15 | 262 |
| K243603 | Aevice Health Pte. , Ltd. | AeviceMD | 2025-05-05 | 165 |
Recalls for DSH devices
openFDA lists no recalls for product code DSH.
Frequently asked questions
What is FDA product code DSH?
DSH is the FDA product code for recorder, magnetic tape, medical. It is a Class II device, regulated under 21 CFR 870.2800 and reviewed by the Cardiovascular panel.
What device class is DSH?
Class II, regulation 21 CFR 870.2800. Typical premarket route: 510(k).
How long does a 510(k) take for product code DSH?
Across 195 cleared submissions the average was 125 days from receipt to decision (median 83).
Which companies have the most DSH clearances?
Del Mar Avionics (15); Bardy Diagnostics, Inc. (7); iRhythm Technologies, Inc. (6); Oxford Medilog, Inc. (6); Cardiocomm Solutions, Inc. (4).
Next steps
- Run an FDA pathway report with predicate devices for product code DSH
- Run a recall and safety report across every DSH manufacturer
- Watch product code DSH 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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