510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MNSClass II

Ventilator, Continuous, Non-Life-Supporting

21 CFR 868.5895 / Anesthesiology
FDA source (opens on fda.gov)

MNS is the FDA product code for Ventilator, Continuous, Non-Life-Supporting, a class II device type, regulated under 21 CFR 868.5895. As of , FDA records hold 47 510(k) clearances under this code, the most recent dated , and 21 recalls.

Classification record

Product code
MNS
Device name
Ventilator, Continuous, Non-Life-Supporting
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
47
Ingested recalls
21

Clearances, product code MNS

By decision year
47 clearances under product code MNS with a decision year between 1996 and 2026, 2012 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code MNS by decision year
YearClearances
19961
19971
19981
19991
20001
20011
20021
20031
20042
20051
20063
20074
20094
20104
20113
20125
20133
20162
20171
20181
20221
20231
20241
20263

Applicants with the most clearances

Product code MNS
Applicants holding the most 510(k) clearances under product code MNS
ApplicantClearances
ResMed Corp19
Respironics, Inc.13
Respironics Inc., Sleep & Home Respiratory Group4
Breas Medical AB2
SMD Manufacturing LLC2
BMC Medical Co., Ltd.1
Compal Electronics, Inc1
Healthdyne Technologies, Inc.1
Innomed Technologies1
Medtronic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order