FDA product code · Anesthesiology · Class 2
MNR: Ventilatory Effort Recorder
MNR is FDA's product code for "Ventilatory Effort Recorder": a Class 2 device classified under 21 CFR 868.2375, reviewed by the Anesthesiology panel.
510(k) review time for MNR
Across 53 510(k) clearances under MNR decided from 2018-01-01 to 2026-10-06, the median was 189 days from FDA receipt to decision. Half took between 137 and 275 days, and 80% were decided within 324 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 137 |
| Median | 189 |
| 75th percentile | 275 |
| 80th percentile | 324 |
| 90th percentile | 434 |
| Slowest | 782 |
| Year | Median days | n |
|---|---|---|
| 2019 | 383 | 8 |
| 2020 | 192 | 5 |
| 2022 | 266 | 7 |
| 2023 | 183 | 6 |
| 2024 | 217 | 6 |
| 2025 | 165 | 10 |
| 2026 (to 10-06, partial) | 227 | 5 |
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.
MNR in the public FDA record
| 510(k) clearances, all years | 164 |
|---|---|
| Establishment listings | 204 |
| GUDID device identifiers | 1,016 |
Counts of records, not of devices or events. Adverse event reports for MNR 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 MNR
No FDA recognized consensus standard cites MNR 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.