Cleared Traditional

K173060 - F&P NivairoTM RT046 Non-Vented Hospital...

K173060 is an FDA 510(k) clearance for F&P NivairoTM RT046 Non-Vented Hospital..., manufactured by Fisher and Paykel Healthcare Limited. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K173060 · Fisher and Paykel Healthcare Limited · Anesthesiology device
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Jan 2018
Decision
119d
Days
Class 2
Risk

K173060 is an FDA 510(k) clearance for the F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Fisher and Paykel Healthcare Limited (Auckland, NZ). The FDA issued a Cleared decision on January 25, 2018 after a review of 119 days - within the typical 510(k) review window.

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 - K173060

510(k) Number K173060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2017
Decision Date January 25, 2018
Days to Decision 119 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
21d faster than avg
Panel avg: 140d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, 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 - CBK Ventilator, Continuous, Facility Use

All 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K173060.
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TV-100
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Puritan Bennett 980 Ventilator System
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731 Series Ventilators
K162832 · ZOLL Medical Corporation · Aug 2017
HAMILTON-C3
K161450 · Hamilton Medical AG · Apr 2017