Cleared Traditional

K170367 - Nivairo RT045 Non-Vented Hospital Full ...

K170367 is an FDA 510(k) clearance for Nivairo RT045 Non-Vented Hospital Full ..., manufactured by Fisher and Paykel Healthcare Limited. The device is a Class 2 Anesthesiology device with product code MNT cleared through the Traditional 510(k) pathway after a 199-day FDA review.

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

FDA 510(k) Submission Details - K170367

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.

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 16
Devices cleared under the same product code (MNT) and FDA review panel - the closest regulatory comparables to K170367.
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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
ACUTE CARE FACE MASK, MODEL RT040
K060044 · Fisher &Paykel Healthcare , Ltd. · Apr 2006