MNS · Class II · 21 CFR 868.5895

FDA Product Code MNS: Ventilator, Continuous, Non-life-supporting

Leading manufacturers include Resmed, Ltd., Respironics, Inc. and Smd Manufacturing, LLC.

47
Total
47
Cleared
159d
Avg days
1996
Since
Growing category - 4 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 272d recently vs 149d historically

FDA 510(k) Cleared Ventilator, Continuous, Non-life-supporting Devices (Product Code MNS)

47 devices
1–24 of 47
Cleared Apr 08, 2026
myAir
K251889
ResMed Corp
Anesthesiology · 292d
Cleared Mar 17, 2026
BreathePal Bilevel (GFM50-MD2201)
K252078
Compal Electronics, Inc.
Anesthesiology · 258d
Cleared Feb 23, 2026
Mariana Minerva
K251661
Resmed Pty , Ltd.
Anesthesiology · 269d
Cleared Dec 13, 2024
Vivo 1, Vivo 2
K240778
Breas Medical AB
Anesthesiology · 267d
Cleared Jul 13, 2023
ReddyPort Elbow
K231064
Smd Manufacturing, LLC
Anesthesiology · 90d
Cleared Dec 05, 2022
BPAP System
K213169
BMC Medical Co., Ltd.
Anesthesiology · 433d
Cleared Jan 19, 2018
ReddyPort NIV Access Elbow
K171827
Smd Manufacturing, LLC
Anesthesiology · 213d
Cleared Jan 19, 2017
Juno VPAP ST-A
K161492
Resmed, Ltd.
Anesthesiology · 232d
Cleared Sep 09, 2016
VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
K161487
Resmed, Ltd.
Anesthesiology · 101d
Cleared Apr 13, 2016
Juno VPAP ST-A
K153061
Resmed, Ltd.
Anesthesiology · 175d
Cleared Nov 22, 2013
EASYCARE ONLINE
K132371
Resmed, Ltd.
Anesthesiology · 115d
Cleared Mar 21, 2013
S9 VPAP TX
K123511
Resmed, Ltd.
Anesthesiology · 128d
Cleared Mar 14, 2013
EASYCARE ONLINE
K123557
Resmed, Ltd.
Anesthesiology · 115d
Cleared Nov 13, 2012
VPAP S-A
K122324
Resmed, Ltd.
Anesthesiology · 104d
Cleared May 25, 2012
VPAP TX
K113714
Resmed, Ltd.
Anesthesiology · 158d
Cleared Mar 29, 2012
VPAP ST-A
K113288
Resmed, Ltd.
Anesthesiology · 143d
Cleared Mar 27, 2012
RESSCAN
K113815
Resmed, Ltd.
Anesthesiology · 95d
Cleared Feb 01, 2012
BIPAP A 30 VENTILATORY SUPPORT SYSTEM
K113053
Respironics, Inc.
Anesthesiology · 111d
Cleared Dec 29, 2011
VPAP TX
K112914
Resmed, Ltd.
Anesthesiology · 87d
Cleared Mar 24, 2011
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
K102465
Respironics, Inc.
Anesthesiology · 209d
Cleared Sep 02, 2010
BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK
K101130
Respironics, Inc.
Anesthesiology · 133d
Cleared Mar 22, 2010
VPAP III ST-A
K093731
Resmed, Ltd.
Anesthesiology · 109d
Cleared Jan 22, 2010
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
K092818
Respironics, Inc.
Anesthesiology · 130d
Cleared Dec 22, 2009
VPAP TX
K092186
Resmed, Ltd.
Anesthesiology · 154d

About Product Code MNS - Regulatory Context

510(k) Submission Activity

47 total 510(k) submissions under product code MNS since 1996, with 47 receiving FDA clearance (average review time: 159 days).

Submission volume has increased in recent years - 4 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 - MNS Product Code

Recent submissions under MNS have taken an average of 272 days to reach a decision - up from 149 days historically. Manufacturers should account for longer review timelines in current project planning.

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