FDA product code · Cardiovascular · Class 2
QME: Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
QME is FDA's product code for "Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate": a Class 2 device classified under 21 CFR 870.2785, reviewed by the Cardiovascular panel.
510(k) review time for QME
Across 12 510(k) clearances under QME decided from 2018-01-01 to 2026-10-06, the median was 190 days from FDA receipt to decision. Half took between 136 and 269 days, and 80% were decided within 270 days. These are past clearances, not a forecast for a new submission.
| Fastest | 29 |
|---|---|
| 25th percentile | 136 |
| Median | 190 |
| 75th percentile | 269 |
| 80th percentile | 270 |
| 90th percentile | 271 |
| Slowest | 290 |
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.
FDA-recognized standards that cite QME
No FDA recognized consensus standard cites QME by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.