Cleared Traditional

K153505 - F&P Eson 2 Nasal Mask

K153505 is an FDA 510(k) clearance for F&P Eson 2 Nasal Mask, manufactured by Fisher & Paykel Healthcare Limited. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K153505 · Fisher & Paykel Healthcare Limited · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
288d
Days
Class 2
Risk

K153505 is an FDA 510(k) clearance for the F&P Eson 2 Nasal Mask. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Fisher & Paykel Healthcare Limited (Auckland, NZ). The FDA issued a Cleared decision on September 20, 2016 after a review of 288 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 Limited devices

FDA 510(k) Submission Details - K153505

510(k) Number K153505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2015
Decision Date September 20, 2016
Days to Decision 288 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
148d slower than avg
Panel avg: 140d · This submission: 288d
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 286
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K153505.
F&P Brevida™ Nasal Pillows Mask
K161412 · Fisher &Paykel Healthcare , Ltd. · Jan 2017
Menai System
K160836 · Resmed, Ltd. · Dec 2016
AirFit N20
K161978 · Resmed, Ltd. · Nov 2016
S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV
K160822 · Resmed, Ltd. · Sep 2016
AirFit F20
K153563 · Resmed, Ltd. · May 2016
AirFit N20
K153673 · Resmed, Ltd. · May 2016