FDA product code · Cardiovascular · Class 2
DXH: Transmitters And Receivers, Electrocardiograph, Telephone
DXH is FDA's product code for "Transmitters And Receivers, Electrocardiograph, Telephone": a Class 2 device classified under 21 CFR 870.2920, reviewed by the Cardiovascular panel.
510(k) review time for DXH
Across 28 510(k) clearances under DXH decided from 2018-01-01 to 2026-10-06, the median was 193 days from FDA receipt to decision. Half took between 126 and 288 days, and 80% were decided within 310 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 126 |
| Median | 193 |
| 75th percentile | 288 |
| 80th percentile | 310 |
| 90th percentile | 349 |
| Slowest | 394 |
| Year | Median days | n |
|---|---|---|
| 2019 | 177 | 6 |
| 2020 | 141 | 5 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
DXH in the public FDA record
| 510(k) clearances, all years | 297 |
|---|---|
| Device recalls | 10 |
| Establishment listings | 156 |
Counts of records, not of devices or events. Adverse event reports for DXH are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite DXH
2 FDA recognized consensus standards cite DXH, among them ISO IEEE 11073-10102 First edition 2014-03-01; ISO 11073-91064 First edition 2009-05-01. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 13-75 ISO IEEE 11073-10102 First edition 2014-03-01 — Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
- 13-76 ISO 11073-91064 First edition 2009-05-01 — Health informatics - Standard communication protocol - Computer-assisted electrocardiography
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.