FDA product code MNS: Ventilator, Continuous, Non-Life-Supporting
MNS is the FDA product code for ventilator, continuous, non-life-supporting. It is a Class II device, regulated under 21 CFR 868.5895 and reviewed by the Anesthesiology panel. FDA has cleared 47 510(k) submissions under MNS, 6 in the last five years, from 15 different applicants. The average 510(k) review took 159 days (median 130); 270 days on average over the last three years. FDA has posted 21 recalls for MNS devices, 12 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Ventilator, Continuous, Non-Life-Supporting |
| Device class | Class II |
| Regulation | 21 CFR 868.5895 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
510(k) clearances per year for MNS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 232 |
| 2018 | 1 | 213 |
| 2022 | 1 | 433 |
| 2023 | 1 | 90 |
| 2024 | 1 | 267 |
| 2026 | 3 | 273 |
Compare with all 510(k) review times · Search every MNS clearance
Top MNS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Resmed, Ltd. | 16 | 2017-01-19 |
| Respironics, Inc. | 12 | 2012-02-01 |
| Respironics Inc., Sleep & Home Respiratory Group | 4 | 2009-10-30 |
| Resmed Corp | 2 | 2026-04-08 |
| Breas Medical AB | 2 | 2024-12-13 |
10 more applicants have MNS clearances. See the full list in Caduvo.
Most recent MNS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251889 | Resmed Corp | myAir | 2026-04-08 | 292 |
| K252078 | Compal Electronics, Inc. | BreathePal Bilevel (GFM50-MD2201) | 2026-03-17 | 258 |
| K251661 | Resmed Pty , Ltd. | Mariana Minerva; Mariana Nimbus | 2026-02-23 | 269 |
| K240778 | Breas Medical AB | Vivo 1, Vivo 2 | 2024-12-13 | 267 |
| K231064 | Smd Manufacturing, LLC | ReddyPort Elbow | 2023-07-13 | 90 |
Recalls for MNS devices
21 product recalls in 10 recall events; 12 initiated in the last five years and 16 still open. Most recent: 2026-07-15.
| Year | Recalls |
|---|---|
| 2021 | 6 |
| 2022 | 6 |
| 2024 | 3 |
| 2025 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code MNS?
MNS is the FDA product code for ventilator, continuous, non-life-supporting. It is a Class II device, regulated under 21 CFR 868.5895 and reviewed by the Anesthesiology panel.
What device class is MNS?
Class II, regulation 21 CFR 868.5895. Typical premarket route: 510(k).
How long does a 510(k) take for product code MNS?
Across 47 cleared submissions the average was 159 days from receipt to decision (median 130).
Which companies have the most MNS clearances?
Resmed, Ltd. (16); Respironics, Inc. (12); Respironics Inc., Sleep & Home Respiratory Group (4); Resmed Corp (2); Breas Medical AB (2).
Have MNS devices been recalled?
Yes: 21 product recalls across 10 recall events; the most recent began 2026-07-15.
Next steps
- Run an FDA pathway report with predicate devices for product code MNS
- Run a recall and safety report across every MNS manufacturer
- Watch product code MNS 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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