Cleared Traditional

K140279 - S9 GREENHILLS

K140279 is an FDA 510(k) clearance for S9 GREENHILLS, 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 178-day FDA review.

K140279 · Resmed, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
178d
Days
Class 2
Risk

K140279 is an FDA 510(k) clearance for the S9 GREENHILLS. 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 July 31, 2014 after a review of 178 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 - K140279

510(k) Number K140279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2014
Decision Date July 31, 2014
Days to Decision 178 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
38d slower than avg
Panel avg: 140d · This submission: 178d
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 K140279.
APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES
K141522 · Apex Medical Corp. · Oct 2014
3B RESMART BPAP 25A, BMC RESMART BPAP 25A
K133769 · 3B Medical, Inc. · Aug 2014
DEVILBISS SMARTLINK II SYSTEM
K140880 · Devilbiss Healthcare, LLC · Aug 2014
S9 WANDA VPAP ST
K140159 · Resmed, Ltd. · Jun 2014
AIRSOFT F15
K132901 · Resmed, Ltd. · Jun 2014
RESCAN
K140054 · Resmed, Ltd. · May 2014