FDA product code DXH: Transmitters And Receivers, Electrocardiograph, Telephone
DXH is the FDA product code for transmitters and receivers, electrocardiograph, telephone. It is a Class II device, regulated under 21 CFR 870.2920 and reviewed by the Cardiovascular panel. FDA has cleared 297 510(k) submissions under DXH, 10 in the last five years, from 145 different applicants. The average 510(k) review took 145 days (median 107); 354 days on average over the last three years. FDA has posted 10 recalls for DXH devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Transmitters And Receivers, Electrocardiograph, Telephone |
| Device class | Class II |
| Regulation | 21 CFR 870.2920 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DXH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 153 |
| 2018 | 4 | 267 |
| 2019 | 6 | 172 |
| 2020 | 5 | 199 |
| 2021 | 3 | 120 |
| 2022 | 4 | 152 |
| 2023 | 1 | 35 |
| 2025 | 4 | 326 |
| 2026 | 1 | 382 |
Compare with all 510(k) review times · Search every DXH clearance
Top DXH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Card Guard Scientific Survival , Ltd. | 28 | 2009-12-17 |
| Instromedix, Inc. | 16 | 1997-07-18 |
| Medtronic Vascular | 15 | 1992-01-30 |
| AliveCor, Inc. | 10 | 2022-05-25 |
| Universal Medical, Inc. | 8 | 2008-12-15 |
140 more applicants have DXH clearances. See the full list in Caduvo.
Most recent DXH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250233 | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | PreemptiveAI Clinical SDK | 2026-02-13 | 382 |
| K250258 | Heartbeam, Inc. | HeartBeam AIMIGo with 12-L ECG Synthesis Software System | 2025-12-08 | 314 |
| K243438 | Huinno Co., Ltd. | MEMO Patch M (MPT-E08R-UNC01) | 2025-12-05 | 394 |
| K243981 | Carre Technologies, Inc. | Hexoskin Medical System (7100-00016) | 2025-11-18 | 330 |
| K243003 | VitalSigns Technology Co., Ltd. | VitalSigns 1-Lead Holter (VSH101) | 2025-06-17 | 264 |
Recalls for DXH devices
10 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-04-21.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code DXH?
DXH is the FDA product code for transmitters and receivers, electrocardiograph, telephone. It is a Class II device, regulated under 21 CFR 870.2920 and reviewed by the Cardiovascular panel.
What device class is DXH?
Class II, regulation 21 CFR 870.2920. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXH?
Across 297 cleared submissions the average was 145 days from receipt to decision (median 107).
Which companies have the most DXH clearances?
Card Guard Scientific Survival , Ltd. (28); Instromedix, Inc. (16); Medtronic Vascular (15); AliveCor, Inc. (10); Universal Medical, Inc. (8).
Have DXH devices been recalled?
Yes: 10 product recalls across 5 recall events; the most recent began 2026-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code DXH
- Run a recall and safety report across every DXH manufacturer
- Watch product code DXH 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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