Cleared Special

K111148 - S8 ASPEN WITH H4I PLUS

K111148 is an FDA 510(k) clearance for S8 ASPEN WITH H4I PLUS, manufactured by ResMed Corp. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Special 510(k) pathway after a 69-day FDA review.

K111148 · ResMed Corp · Anesthesiology device
Download Printable Device Report (PDF)
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Jun 2011
Decision
69d
Days
Class 2
Risk

K111148 is an FDA 510(k) clearance for the S8 ASPEN WITH H4I PLUS. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by ResMed Corp (San Diego, US). The FDA issued a Cleared decision on June 30, 2011 after a review of 69 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all ResMed Corp devices

FDA 510(k) Submission Details - K111148

510(k) Number K111148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2011
Decision Date June 30, 2011
Days to Decision 69 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 140d · This submission: 69d
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 286
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