Cleared Traditional

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) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170367 · Fisher and Paykel Healthcare Limited · Anesthesiology device
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Aug 2017
Decision
199d
Days
Class 2
Risk

K170367 is an FDA 510(k) clearance for the Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - La.... Classified as Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (product code MNT), Class II - Special Controls.

Submitted by Fisher and Paykel Healthcare Limited (Auckland, NZ). The FDA issued a Cleared decision on August 24, 2017 after a review of 199 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 and Paykel Healthcare Limited devices

Submission Details

510(k) Number K170367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2017
Decision Date August 24, 2017
Days to Decision 199 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 140d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 13
Devices cleared under the same product code (MNT) and FDA review panel - the closest regulatory comparables to K170367.
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
F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version
K191624 · Fisher & Paykel Healthcare Limited · Mar 2020
BIPAP A 40 VENTILATORY SUPPORT SYSTEM
K121623 · Respironics, Inc. · Dec 2012
V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
K102985 · Respironics, Inc. · Apr 2011
STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964
K990574 · Respironics, Inc. · May 1999