Cleared Special

K110246 - MEDISIZE RED AND MEDISIZE BLUE

K110246 is an FDA 510(k) clearance for MEDISIZE RED AND MEDISIZE BLUE, manufactured by Qserve America, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Special 510(k) pathway after a 281-day FDA review.

K110246 · Qserve America, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
281d
Days
Class 2
Risk

K110246 is an FDA 510(k) clearance for the MEDISIZE RED AND MEDISIZE BLUE. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Qserve America, Inc. (Claremont, US). The FDA issued a Cleared decision on November 4, 2011 after a review of 281 days - an extended review 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. 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 - K110246

510(k) Number K110246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2011
Decision Date November 04, 2011
Days to Decision 281 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 129d · This submission: 281d
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 175
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K110246.
WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]
K121382 · Westmed, Inc. · Dec 2012
FLO-GUARD BREATHING FILTER
K121026 · Intersurgical, Inc. · Nov 2012
HUMID-VENT HEPA
K112958 · Teleflex Medical · Sep 2012
MICROGARD II
K111408 · Carefusion Germany 234 GmbH · Oct 2011
SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104
K102483 · Sunset Healthcare Solutions, LLC · Sep 2011
INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER
K092451 · Intersurgical, Inc. · Oct 2010
K110246 · MEDISIZE RED AND MEDISIZE BLUE
Download PDF Qserve America, Inc.