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

Continuous, Minimal Ventilatory Support, Facility Use Ventilator

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

MNT is the FDA product code for Sv70 Ventilator, a class II device type, regulated under 21 CFR 868.5895. As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and 64 recalls.

Classification record

Product code
MNT
Device name
Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
25
Ingested recalls
64

Clearances, product code MNT

By decision year
25 clearances under product code MNT with a decision year between 1996 and 2026, 1998 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MNT by decision year
YearClearances
19962
19983
19991
20011
20062
20081
20092
20112
20122
20131
20171
20201
20221
20231
20242
20251
20261

Applicants with the most clearances

Product code MNT
Applicants holding the most 510(k) clearances under product code MNT
ApplicantClearances
Respironics, Inc.7
Breas Medical AB4
Fisher & Paykel Healthcare, Inc.4
Resmed Germany, Inc.3
Mallinckrodt, Inc.1
Maquet Critical Care AB1
Mekics Co., Ltd.1
Nihon Kohden Orangemed, LLC1
Medtronic, Inc.1
ResMed Corp1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order