Cleared Traditional

K132887 - AIRFIT N10

K132887 is an FDA 510(k) clearance for AIRFIT N10, manufactured by Resmed, Ltd.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K132887 · Resmed, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
95d
Days
Class 2
Risk

K132887 is an FDA 510(k) clearance for the AIRFIT N10. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed, Ltd. (San Diego, US). The FDA issued a Cleared decision on December 20, 2013 after a review of 95 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

FDA 510(k) Submission Details - K132887

510(k) Number K132887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2013
Decision Date December 20, 2013
Days to Decision 95 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
45d faster than avg
Panel avg: 140d · This submission: 95d
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 391
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K132887.
K SERIES CPAP SYSTEMS
K130828 · Curative Medical, Inc. · Jan 2014
S9 CRONULLA FOR HER
K132606 · Resmed, Ltd. · Jan 2014
IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2
K131901 · 3B Medical, Inc. · Dec 2013
K SERIES CPAP SYSTEMS
K131702 · Curative Medical, Inc. · Dec 2013
3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP
K132967 · 3B Medical, Inc. · Dec 2013
BRONCHOSCOPY ELBOW
K132168 · Respironics, Inc. · Nov 2013