Cleared Special

K011132 - AIRLIFE HEPA FILTER

K011132 is an FDA 510(k) clearance for AIRLIFE HEPA FILTER, manufactured by Allegiance Healthcare Corp.. The device is a Class 2 General Hospital device with product code CAH cleared through the Special 510(k) pathway after a 56-day FDA review.

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

FDA 510(k) Submission Details - K011132

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

CAH Device Classification - Class 2, Special Controls

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 79
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K011132.
DATEX-OHMEDA HMEF 500
K021265 · Datex-Ohmeda · Aug 2002
TERUMO GAS FILTER
K021020 · Terumo Cardiovascular Systems Corp. · Jun 2002
END EXPIRATORY FILTER, MODEL RT020
K002839 · Fisher &Paykel Healthcare , Ltd. · Oct 2001
72 HOUR USE TRACH CARE WITH MICROBAN
K974630 · Ballard Medical Products · Mar 1998
ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
K962045 · Mallinckrodt Medical · Nov 1996
RESPIRGARD II, SPIROGARD
K961838 · Marquest Medical Products, Inc. · Oct 1996