FDA product code · Cardiovascular · Class 2
DRT: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DRT is FDA's product code for "Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)": a Class 2 device classified under 21 CFR 870.2300, reviewed by the Cardiovascular panel.
510(k) review time for DRT
Across 14 510(k) clearances under DRT decided from 2018-01-01 to 2026-10-06, the median was 242 days from FDA receipt to decision. Half took between 162 and 295 days, and 80% were decided within 302 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 162 |
| Median | 242 |
| 75th percentile | 295 |
| 80th percentile | 302 |
| 90th percentile | 313 |
| Slowest | 446 |
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.
DRT in the public FDA record
| 510(k) clearances, all years | 339 |
|---|---|
| Device recalls | 11 |
| Establishment listings | 290 |
| GUDID device identifiers | 539 |
Counts of records, not of devices or events. Adverse event reports for DRT 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 DRT
7 FDA recognized consensus standards cite DRT, 2 of them recognized only in part, among them IEEE Std 11073-10406-2023; IEEE Std 11073-10406-2011; ISO IEEE 11073-10102 First edition 2014-03-01. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 13-147 IEEE Std 11073-10406-2023 — Health informatics - Device Interoperability Part 10406: Personal health device communication - Device Specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
- 13-56 IEEE Std 11073-10406-2011 — Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
- 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
- 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
- 3-203 IEC 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION (partial recognition) — Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.