MNT · Sv70 Ventilator
Anesthesiology · 21 CFR 868.5895 · Class 2
Overview
| Product Code | MNT |
|---|---|
| Device Name | Sv70 Ventilator |
| Regulation | 21 CFR 868.5895 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 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 | SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Apr 6, 2026 | SESE |
| K242931 | HFT750U | Mekics Co., Ltd. | May 15, 2025 | SESE |
| K240779 | Vivo 3 | Breas Medical AB | Dec 13, 2024 | SESE |
| K233643 | F&P Airvo 3 NIV (PT311US) | Fisher & Paykel Healthcare, Ltd. | Aug 9, 2024 | SESE |
| K230173 | Servo-air Lite Ventilator System | Maquet Critical Care AB | Jul 6, 2023 | SESE |
| K213521 | Nihon Kohden NKV-330 Ventilator System | Nihon Kohden Orangemed, Inc. | Jul 1, 2022 | SESE |
| K191624 | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version | Fisher & Paykel Healthcare Limited | Mar 9, 2020 | SESE |
| K170367 | 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 | STELLAR 150 | Resmed Germany, Inc. | Jun 17, 2013 | SESE |
| K121623 | BIPAP A 40 VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | Dec 14, 2012 | SESE |
| K113640 | STELLAR 150 | Resmed Germany, Inc. | Apr 5, 2012 | SESE |
| K102985 | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS | Respironics, Inc. | Apr 5, 2011 | SESE |
| K103167 | STELLAR 150 | Resmed Germany, Inc. | Mar 1, 2011 | SESE |
| K090113 | BREAS VIVO 40 SYSTEM | Breas Medical AB | May 14, 2009 | SESE |
| K082660 | V60 VENTILATOR, MODEL V8000 | Respironics California, Inc. | Jan 9, 2009 | SESE |
| K071702 | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 | Breas Medical AB | Feb 15, 2008 | SESE |
| K060044 | ACUTE CARE FACE MASK, MODEL RT040 | Fisher & Paykel Healthcare, Ltd. | Apr 6, 2006 | SESE |
| K053607 | BREAS VIVO 40 SYSTEM | Breas Medical AB | Mar 16, 2006 | SESE |
| K003075 | KNIGHTSTAR 330 VENTILATOR | Mallinckrodt, Inc. | Dec 11, 2001 | ST |
| K990574 | 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
