Cleared Special

K113227 - NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER (FDA 510(k) Clearance)

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

K113227 · Baxter Healthcare Corp · General Hospital
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Optimized for regulatory review, auditing and printing
Dec 2011
Decision
37d
Days
Class 2
Risk

K113227 is an FDA 510(k) clearance for the NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Deerfield, US). The FDA issued a Cleared decision on December 8, 2011 after a review of 37 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K113227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2011
Decision Date December 08, 2011
Days to Decision 37 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
91d faster than avg
Panel avg: 128d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FPB Filter, Infusion Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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.