Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5895](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5895) → MNT — Sv70 Ventilator # MNT · Sv70 Ventilator _Anesthesiology · 21 CFR 868.5895 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT ## Overview - **Product Code:** MNT - **Device Name:** Sv70 Ventilator - **Regulation:** [21 CFR 868.5895](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5895) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **Life-sustaining:** yes ## Identification A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 25) Showing 20 most recent of 25 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252182](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K252182.md) | SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Apr 6, 2026 | SESE | | [K242931](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K242931.md) | HFT750U | Mekics Co., Ltd. | May 15, 2025 | SESE | | [K240779](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K240779.md) | Vivo 3 | Breas Medical AB | Dec 13, 2024 | SESE | | [K233643](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K233643.md) | F&P Airvo 3 NIV (PT311US) | Fisher & Paykel Healthcare, Ltd. | Aug 9, 2024 | SESE | | [K230173](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K230173.md) | Servo-air Lite Ventilator System | Maquet Critical Care AB | Jul 6, 2023 | SESE | | [K213521](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K213521.md) | Nihon Kohden NKV-330 Ventilator System | Nihon Kohden Orangemed, Inc. | Jul 1, 2022 | SESE | | [K191624](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K191624.md) | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version | Fisher & Paykel Healthcare Limited | Mar 9, 2020 | SESE | | [K170367](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K170367.md) | Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small | Fisher and Paykel Healthcare Limited | Aug 24, 2017 | SESE | | [K122715](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K122715.md) | STELLAR 150 | Resmed Germany, Inc. | Jun 17, 2013 | SESE | | [K121623](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K121623.md) | BIPAP A 40 VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | Dec 14, 2012 | SESE | | [K113640](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K113640.md) | STELLAR 150 | Resmed Germany, Inc. | Apr 5, 2012 | SESE | | [K102985](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K102985.md) | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS | Respironics, Inc. | Apr 5, 2011 | SESE | | [K103167](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K103167.md) | STELLAR 150 | Resmed Germany, Inc. | Mar 1, 2011 | SESE | | [K090113](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K090113.md) | BREAS VIVO 40 SYSTEM | Breas Medical AB | May 14, 2009 | SESE | | [K082660](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K082660.md) | V60 VENTILATOR, MODEL V8000 | Respironics California, Inc. | Jan 9, 2009 | SESE | | [K071702](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K071702.md) | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 | Breas Medical AB | Feb 15, 2008 | SESE | | [K060044](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K060044.md) | ACUTE CARE FACE MASK, MODEL RT040 | Fisher & Paykel Healthcare, Ltd. | Apr 6, 2006 | SESE | | [K053607](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K053607.md) | BREAS VIVO 40 SYSTEM | Breas Medical AB | Mar 16, 2006 | SESE | | [K003075](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K003075.md) | KNIGHTSTAR 330 VENTILATOR | Mallinckrodt, Inc. | Dec 11, 2001 | ST | | [K990574](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT/K990574.md) | STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 | Respironics, Inc. | May 24, 1999 | ST | ## Top Applicants - Respironics, Inc. — 6 clearances - Breas Medical AB — 4 clearances - Resmed Germany, Inc. — 3 clearances - Fisher & Paykel Healthcare, Ltd. — 2 clearances - Fisher & Paykel Healthcare Limited — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MNT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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