Cleared Special

K011132 - AIRLIFE HEPA FILTER (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K011132 · Allegiance Healthcare Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
56d
Days
Class 2
Risk

K011132 is an FDA 510(k) clearance for the AIRLIFE HEPA FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on June 8, 2001 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital 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 Allegiance Healthcare Corp. devices

Submission Details

510(k) Number K011132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2001
Decision Date June 08, 2001
Days to Decision 56 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 128d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 200
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K011132.
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