FDA product code MNR: Ventilatory Effort Recorder
MNR is the FDA product code for ventilatory effort recorder. It is a Class II device, regulated under 21 CFR 868.2375 and reviewed by the Anesthesiology panel. FDA has cleared 164 510(k) submissions under MNR, 33 in the last five years, from 88 different applicants. The average 510(k) review took 200 days (median 170); 212 days on average over the last three years. FDA has posted 7 recalls for MNR devices.
Classification
| Field | Value |
|---|---|
| Device name | Ventilatory Effort Recorder |
| Device class | Class II |
| Regulation | 21 CFR 868.2375 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MNR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 276 |
| 2018 | 3 | 146 |
| 2019 | 8 | 414 |
| 2020 | 5 | 215 |
| 2021 | 3 | 197 |
| 2022 | 7 | 248 |
| 2023 | 6 | 174 |
| 2024 | 6 | 239 |
| 2025 | 10 | 163 |
| 2026 | 4 | 234 |
Compare with all 510(k) review times · Search every MNR clearance
Top MNR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Itamar Medical , Ltd. | 11 | 2026-07-31 |
| Respironics, Inc. | 6 | 2019-10-18 |
| Snap Laboratories, LLC | 6 | 2008-05-23 |
| Resmed Germany, Inc. | 5 | 2015-04-30 |
| Advanced Brain Monitoring, Inc. | 5 | 2012-01-09 |
83 more applicants have MNR clearances. See the full list in Caduvo.
Most recent MNR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254042 | Itamar Medical , Ltd. | WatchPAT SW | 2026-07-31 | 227 |
| K260050 | Huneo, LLC | WRAP System | 2026-07-15 | 189 |
| K253148 | Vivaquant, Inc. Dba Rhythm Express | RX-1 Sleep | 2026-06-22 | 270 |
| K252628 | Wesper, Inc. | CASSIE | 2026-04-27 | 250 |
| K252497 | Huxley Medical | SANSA HSAT | 2025-12-10 | 124 |
Recalls for MNR devices
7 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-09-07.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code MNR?
MNR is the FDA product code for ventilatory effort recorder. It is a Class II device, regulated under 21 CFR 868.2375 and reviewed by the Anesthesiology panel.
What device class is MNR?
Class II, regulation 21 CFR 868.2375. Typical premarket route: 510(k).
How long does a 510(k) take for product code MNR?
Across 164 cleared submissions the average was 200 days from receipt to decision (median 170).
Which companies have the most MNR clearances?
Itamar Medical , Ltd. (11); Respironics, Inc. (6); Snap Laboratories, LLC (6); Resmed Germany, Inc. (5); Advanced Brain Monitoring, Inc. (5).
Have MNR devices been recalled?
Yes: 7 product recalls across 6 recall events; the most recent began 2021-09-07.
Next steps
- Run an FDA pathway report with predicate devices for product code MNR
- Run a recall and safety report across every MNR manufacturer
- Watch product code MNR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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