Cleared Traditional

K191624 - F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version

K191624 is an FDA 510(k) clearance for F&P Nivairo RT047 Vented Hospital Full ..., manufactured by Fisher & Paykel Healthcare Limited. The device is a Class 2 Anesthesiology device with product code MNT cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K191624 · Fisher & Paykel Healthcare Limited · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
265d
Days
Class 2
Risk

K191624 is an FDA 510(k) clearance for the F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Ver.... Classified as Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (product code MNT), Class II - Special Controls.

Submitted by Fisher & Paykel Healthcare Limited (Auckland, NZ). The FDA issued a Cleared decision on March 9, 2020 after a review of 265 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fisher & Paykel Healthcare Limited devices

FDA 510(k) Submission Details - K191624

510(k) Number K191624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2019
Decision Date March 09, 2020
Days to Decision 265 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 140d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNT Device Classification - Class 2, Special Controls

Product Code MNT Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - MNT Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

All 24
Devices cleared under the same product code (MNT) and FDA review panel - the closest regulatory comparables to K191624.
F&P Airvo 3 NIV (PT311US)
K233643 · Fisher &Paykel Healthcare , Ltd. · Aug 2024
Servo-air Lite Ventilator System
K230173 · Maquet Critical Care AB · Jul 2023
Nihon Kohden NKV-330 Ventilator System
K213521 · Nihon Kohden Orangemed, Inc. · Jul 2022
Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small
K170367 · Fisher and Paykel Healthcare Limited · Aug 2017
STELLAR 150
K122715 · Resmed Germany, Inc. · Jun 2013
BIPAP A 40 VENTILATORY SUPPORT SYSTEM
K121623 · Respironics, Inc. · Dec 2012