FDA product code · Cardiovascular · Class 2
DSI: Detector And Alarm, Arrhythmia
DSI is FDA's product code for "Detector And Alarm, Arrhythmia": a Class 2 device classified under 21 CFR 870.1025, reviewed by the Cardiovascular panel.
510(k) review time for DSI
Across 12 510(k) clearances under DSI decided from 2018-01-01 to 2026-10-06, the median was 198 days from FDA receipt to decision. Half took between 167 and 255 days, and 80% were decided within 269 days. These are past clearances, not a forecast for a new submission.
| Fastest | 103 |
|---|---|
| 25th percentile | 167 |
| Median | 198 |
| 75th percentile | 255 |
| 80th percentile | 269 |
| 90th percentile | 280 |
| Slowest | 452 |
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.
DSI in the public FDA record
| 510(k) clearances, all years | 398 |
|---|---|
| Device recalls | 82 |
| Establishment listings | 365 |
| GUDID device identifiers | 692 |
Counts of records, not of devices or events. Adverse event reports for DSI 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 DSI
2 FDA recognized consensus standards cite DSI, 1 of them recognized only in part, among them ANSI AAMI EC57:2012; ANSI AAMI EC53:2013/(R)2020. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 3-118 ANSI AAMI EC57:2012 — Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
- 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.