510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K974539Substantially Equivalent

Sullivan Vpap II St Ventilatory Support System

ResMed Corp, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974539 is the FDA 510(k) clearance record for SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM, a class II device, cleared for Resmed, Ltd. on under FDA product code MNT (Sv70 Ventilator). FDA records list 123 510(k) clearances for Resmed, Ltd., from to . As of , FDA records show no recalls naming K974539.

Clearance record

Decision date
Received
(246 days to decision)
Product code
MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Resmed, Ltd. 10121 Carroll Canyon Rd., San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code MNT

Trailing 12 months
1 clearance under product code MNT in the twelve months to November 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MNT, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260