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
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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.

View all Qserve America, Inc. devices

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
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 105
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K110246.
RT016 INSPIRATORY FILTER
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K112958 · Teleflex Medical · Sep 2012
INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER
K092451 · Intersurgical, Inc. · Oct 2010
HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER
K092409 · Intersurgical, Inc. · Mar 2010
RT019 INSPIRATORY/EXPIRATORY FILTER
K050927 · Fisher &Paykel Healthcare , Ltd. · Aug 2005