Cleared Traditional

K161412 - F&P Brevida™ Nasal Pillows Mask

K161412 is an FDA 510(k) clearance for F&P Brevida Nasal Pillows Mask, manufactured by Fisher &Paykel Healthcare , Ltd.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K161412 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
243d
Days
Class 2
Risk

K161412 is an FDA 510(k) clearance for the F&P Brevida™ Nasal Pillows Mask. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on January 18, 2017 after a review of 243 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 , Ltd. devices

FDA 510(k) Submission Details - K161412

510(k) Number K161412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2016
Decision Date January 18, 2017
Days to Decision 243 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
103d slower than avg
Panel avg: 140d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 428
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K161412.
Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
K163464 · Bmc Medical., Ltd. · Sep 2017
SleepWeaver 3D Nasal Mask
K162905 · Circadiance, LLC · Mar 2017
F&P InfoSmart
K161686 · Fisher &Paykel Healthcare , Ltd. · Jan 2017
Menai System
K160836 · Resmed, Ltd. · Dec 2016
AirFit N20
K161978 · Resmed, Ltd. · Nov 2016
iCodeConnect
K160127 · 3B Medical, Inc. · Nov 2016