FDA product code · Cardiovascular · Class 2
DSH: Recorder, Magnetic Tape, Medical
DSH is FDA's product code for "Recorder, Magnetic Tape, Medical": a Class 2 device classified under 21 CFR 870.2800, reviewed by the Cardiovascular panel.
510(k) review time for DSH
Across 32 510(k) clearances under DSH decided from 2018-01-01 to 2026-10-06, the median was 228 days from FDA receipt to decision. Half took between 83 and 267 days, and 80% were decided within 270 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 83 |
| Median | 228 |
| 75th percentile | 267 |
| 80th percentile | 270 |
| 90th percentile | 306 |
| Slowest | 667 |
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.
DSH in the public FDA record
| 510(k) clearances, all years | 195 |
|---|---|
| Establishment listings | 110 |
Counts of records, not of devices or events. Adverse event reports for DSH 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 DSH
1 FDA recognized consensus standard cite DSH, 1 of them recognized only in part, among them ANSI AAMI EC53:2013/(R)2020. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 3-129 ANSI AAMI EC53:2013/(R)2020 (partial recognition) — ECG trunk cables and patient leadwires
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.