Cleared Traditional

PILAIRO NASAL PILLOWS MASK (K120027) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120027 · Fisher & Paykel Healthcare Limited · Anesthesiology device
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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

Submission Details

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.

Device Classification

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 119
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K120027.
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K121631 · Respironics, Inc. · Oct 2012
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K120562 · Respironics, Inc. · Jul 2012
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K120145 · Respironics, Inc. · Mar 2012
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K113068 · Respironics, Inc. · Dec 2011
TRUBLUE NASAL MASK
K110405 · Respironics, Inc. · Jun 2011
PERFORMAX TOTAL FACE MASK
K103395 · Respironics, Inc. · Mar 2011