Cleared Special

K112489 - SWIFT FX BELLA

K112489 is an FDA 510(k) clearance for SWIFT FX BELLA, manufactured by Resmed, Ltd.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Special 510(k) pathway after a 100-day FDA review.

K112489 · Resmed, Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
100d
Days
Class 2
Risk

K112489 is an FDA 510(k) clearance for the SWIFT FX BELLA. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed, Ltd. (Bella Vist Nsw, AU). The FDA issued a Cleared decision on December 7, 2011 after a review of 100 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K112489

510(k) Number K112489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2011
Decision Date December 07, 2011
Days to Decision 100 days
Submission Type Special
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
40d faster than avg
Panel avg: 140d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

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 462
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K112489 · SWIFT FX BELLA
Download PDF FDA Summary Resmed, Ltd.