Cleared Traditional

K153673 - AirFit N20

K153673 is the FDA 510(k) clearance for AirFit N20 by Resmed, Ltd.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K153673 · Resmed, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
133d
Days
Class 2
Risk

K153673 is an FDA 510(k) clearance for the AirFit N20. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed, Ltd. (Bella Vista Nsw 2153, AU). The FDA issued a Cleared decision on May 2, 2016 after a review of 133 days - within the typical 510(k) review window.

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 Resmed, Ltd. devices

Submission Details

510(k) Number K153673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2015
Decision Date May 02, 2016
Days to Decision 133 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
7d faster than avg
Panel avg: 140d · This submission: 133d
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 Consultant

Resmed Corp
Larissa D'Andrea

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BZD Ventilator, Non-continuous (respirator)

All 246
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K153673.
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
Simple T Pediatric Nasal Mask
K151120 · Respironics, Inc. · Apr 2016
Sapphire
K152356 · Respironics, Inc. · Jan 2016
AF541 EE Full Face Mask
K150639 · Respironics, Inc. · Sep 2015