MNT · Class II · 21 CFR 868.5895

FDA Product Code MNT: Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

Leading manufacturers include Respironics, Inc., Breas Medical AB and Resmed Germany, Inc..

25
Total
25
Cleared
223d
Avg days
1996
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 256d recently vs 218d historically

FDA 510(k) Cleared Ventilator, Continuous, Minimal Ventilatory Support, Facility Use Devices (Product Code MNT)

25 devices
1–24 of 25
Cleared Apr 06, 2026
SV70 Ventilator (SV70)
K252182
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Anesthesiology · 269d
Cleared May 15, 2025
HFT750U
K242931
Mekics Co., Ltd.
Anesthesiology · 232d
Cleared Dec 13, 2024
Vivo 3
K240779
Breas Medical AB
Anesthesiology · 267d
Cleared Aug 09, 2024
F&P Airvo 3 NIV (PT311US)
K233643
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 270d
Cleared Jul 06, 2023
Servo-air Lite Ventilator System
K230173
Maquet Critical Care AB
Anesthesiology · 167d
Cleared Jul 01, 2022
Nihon Kohden NKV-330 Ventilator System
K213521
Nihon Kohden Orangemed, Inc.
Anesthesiology · 240d
Cleared Mar 09, 2020
F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version
K191624
Fisher & Paykel Healthcare Limited
Anesthesiology · 265d
Cleared Aug 24, 2017
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
K170367
Fisher and Paykel Healthcare Limited
Anesthesiology · 199d
Cleared Jun 17, 2013
STELLAR 150
K122715
Resmed Germany, Inc.
Anesthesiology · 285d
Cleared Dec 14, 2012
BIPAP A 40 VENTILATORY SUPPORT SYSTEM
K121623
Respironics, Inc.
Anesthesiology · 196d
Cleared Apr 05, 2012
STELLAR 150
K113640
Resmed Germany, Inc.
Anesthesiology · 118d
Cleared Apr 05, 2011
V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
K102985
Respironics, Inc.
Anesthesiology · 180d
Cleared Mar 01, 2011
STELLAR 150
K103167
Resmed Germany, Inc.
Anesthesiology · 125d
Cleared May 14, 2009
BREAS VIVO 40 SYSTEM
K090113
Breas Medical AB
Anesthesiology · 113d
Cleared Jan 09, 2009
V60 VENTILATOR, MODEL V8000
K082660
Respironics California, Inc.
Anesthesiology · 119d
Cleared Feb 15, 2008
BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40
K071702
Breas Medical AB
Anesthesiology · 239d
Cleared Apr 06, 2006
ACUTE CARE FACE MASK, MODEL RT040
K060044
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 90d
Cleared Mar 16, 2006
BREAS VIVO 40 SYSTEM
K053607
Breas Medical AB
Anesthesiology · 79d
Cleared Dec 11, 2001
KNIGHTSTAR 330 VENTILATOR
K003075
Mallinckrodt, Inc.
Anesthesiology · 434d
Cleared May 24, 1999
STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964
K990574
Respironics, Inc.
Anesthesiology · 90d
Cleared Nov 03, 1998
BIPAP VISION VENTILATORY SUPPORT
K982454
Respironics, Inc.
Anesthesiology · 111d
Cleared Aug 06, 1998
SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM
K974539
Resmed, Ltd.
Anesthesiology · 246d
Cleared Jul 16, 1998
KNIGHTSTAR 335
K973004
Puritan Bennett Corp.
Anesthesiology · 337d
Cleared Dec 20, 1996
BIPAP S/T-D 30 SYSTEM
K955324
Respironics, Inc.
Anesthesiology · 396d

About Product Code MNT - Regulatory Context

510(k) Submission Activity

25 total 510(k) submissions under product code MNT since 1996, with 25 receiving FDA clearance (average review time: 223 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MNT Product Code

Recent submissions under MNT have taken an average of 256 days to reach a decision - up from 218 days historically. Manufacturers should account for longer review timelines in current project planning.

MNT devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →