Cleared Traditional

K120027 - PILAIRO NASAL PILLOWS MASK

K120027 is an FDA 510(k) clearance for PILAIRO NASAL PILLOWS 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 51-day FDA review.

K120027 · Fisher & Paykel Healthcare Limited · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
51d
Days
Class 2
Risk

K120027 is an FDA 510(k) clearance for the PILAIRO NASAL PILLOWS 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 February 23, 2012 after a review of 51 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fisher & Paykel Healthcare Limited devices

FDA 510(k) Submission Details - K120027

510(k) Number K120027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2012
Decision Date February 23, 2012
Days to Decision 51 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
89d faster than avg
Panel avg: 140d · This submission: 51d
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 K120027.
APEX MEDICAL ICH CPAP SERIES (9S-007XXX)
K120035 · Apex Medical Corp. · May 2012
EASYCARE TX SYSTEM (CONNEXUNS)
K113780 · Resmed, Ltd. · Apr 2012
SIMPLE T NASAL MASK
K120145 · Respironics, Inc. · Mar 2012
MIRAGE QUATTRO
K113127 · Resmed, Ltd. · Jan 2012
REMSTAR AUTO A-FLEX HT
K113068 · Respironics, Inc. · Dec 2011
SWIFT FX BELLA
K112489 · Resmed, Ltd. · Dec 2011