510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K191624Substantially Equivalent

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version

Fisher & Paykel Healthcare, Inc., Auckland, NZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191624 is the FDA 510(k) clearance record for F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version, a class II device, cleared for Fisher & Paykel Healthcare Limited on under FDA product code MNT (Sv70 Ventilator). FDA records list 86 510(k) clearances for Fisher & Paykel Healthcare Limited, from to . As of , FDA records show no recalls naming K191624.

Clearance record

Decision date
Received
(265 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
Fisher & Paykel Healthcare Limited 15 Maurice Paykel Pl., Auckland, NZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MNT

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