Cleared Traditional

K170924 - AirFit F20

K170924 is an FDA 510(k) clearance for AirFit F20, 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 280-day FDA review.

K170924 · Resmed, Ltd. · Anesthesiology device
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Jan 2018
Decision
280d
Days
Class 2
Risk

K170924 is an FDA 510(k) clearance for the AirFit F20. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed, Ltd. (Bella Vista, AU). The FDA issued a Cleared decision on January 3, 2018 after a review of 280 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 Resmed, Ltd. devices

FDA 510(k) Submission Details - K170924

510(k) Number K170924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2017
Decision Date January 03, 2018
Days to Decision 280 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
140d slower than avg
Panel avg: 140d · This submission: 280d
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 Consultant

Resmed Corp (Registration Number: 3007573469)
Sheila Bruschi

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 391
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K170924.
F&P SleepStyle
K173193 · Fisher &Paykel Healthcare , Ltd. · Aug 2018
Scone Mask
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Bleep DreamPort
K172335 · Snapcpap · Mar 2018
AirFit N20
K171212 · Resmed, Ltd. · Sep 2017
Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
K163464 · Bmc Medical., Ltd. · Sep 2017
SleepWeaver 3D Nasal Mask
K162905 · Circadiance, LLC · Mar 2017