FDA product code · Cardiovascular · Class 2
MWJ: Electrocardiograph, Ambulatory (Without Analysis)
MWJ is FDA's product code for "Electrocardiograph, Ambulatory (Without Analysis)": a Class 2 device classified under 21 CFR 870.2800, reviewed by the Cardiovascular panel.
510(k) review time for MWJ
Across 13 510(k) clearances under MWJ decided from 2018-01-01 to 2026-10-06, the median was 268 days from FDA receipt to decision. Half took between 230 and 295 days, and 80% were decided within 384 days. These are past clearances, not a forecast for a new submission.
| Fastest | 20 |
|---|---|
| 25th percentile | 230 |
| Median | 268 |
| 75th percentile | 295 |
| 80th percentile | 384 |
| 90th percentile | 464 |
| Slowest | 576 |
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.
MWJ in the public FDA record
| 510(k) clearances, all years | 63 |
|---|---|
| GUDID device identifiers | 467 |
Counts of records, not of devices or events. Adverse event reports for MWJ 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 MWJ
1 FDA recognized consensus standard cite MWJ, 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.