FDA product code MNT: Sv70 Ventilator
MNT is the FDA product code for sv70 ventilator. It is a Class II device, regulated under 21 CFR 868.5895 and reviewed by the Anesthesiology panel. FDA has cleared 25 510(k) submissions under MNT, 6 in the last five years, from 14 different applicants. The average 510(k) review took 223 days (median 232); 256 days on average over the last three years. FDA has posted 64 recalls for MNT devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Sv70 Ventilator |
| Device class | Class II |
| Regulation | 21 CFR 868.5895 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for MNT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 199 |
| 2020 | 1 | 265 |
| 2022 | 1 | 240 |
| 2023 | 1 | 167 |
| 2024 | 2 | 268 |
| 2025 | 1 | 232 |
| 2026 | 1 | 269 |
Top MNT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Respironics, Inc. | 6 | 2012-12-14 |
| Breas Medical AB | 4 | 2024-12-13 |
| Resmed Germany, Inc. | 3 | 2013-06-17 |
| Fisher & Paykel Healthcare, Ltd. | 2 | 2024-08-09 |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 1 | 2026-04-06 |
9 more applicants have MNT clearances. See the full list in Caduvo.
Most recent MNT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252182 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | SV70 Ventilator (SV70) | 2026-04-06 | 269 |
| K242931 | Mekics Co., Ltd. | HFT750U | 2025-05-15 | 232 |
| K240779 | Breas Medical AB | Vivo 3 | 2024-12-13 | 267 |
| K233643 | Fisher & Paykel Healthcare, Ltd. | F&P Airvo 3 NIV (PT311US) | 2024-08-09 | 270 |
| K230173 | Maquet Critical Care AB | Servo-air Lite Ventilator System | 2023-07-06 | 167 |
Recalls for MNT devices
64 product recalls in 23 recall events; 9 initiated in the last five years and 33 still open. Most recent: 2025-05-09.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2019 | 5 |
| 2020 | 34 |
| 2021 | 7 |
| 2022 | 5 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code MNT?
MNT is the FDA product code for sv70 ventilator. It is a Class II device, regulated under 21 CFR 868.5895 and reviewed by the Anesthesiology panel.
What device class is MNT?
Class II, regulation 21 CFR 868.5895. Typical premarket route: 510(k).
How long does a 510(k) take for product code MNT?
Across 25 cleared submissions the average was 223 days from receipt to decision (median 232).
Which companies have the most MNT clearances?
Respironics, Inc. (6); Breas Medical AB (4); Resmed Germany, Inc. (3); Fisher & Paykel Healthcare, Ltd. (2); Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (1).
Have MNT devices been recalled?
Yes: 64 product recalls across 23 recall events; the most recent began 2025-05-09.
Next steps
- Run an FDA pathway report with predicate devices for product code MNT
- Run a recall and safety report across every MNT manufacturer
- Watch product code MNT 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.