Cleared Traditional

K132905 - 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K132905 · Arteriocyte Medical Systems, Inc. · General Hospital
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Oct 2013
Decision
18d
Days
Class 2
Risk

K132905 is an FDA 510(k) clearance for the 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER. Classified as Set, Blood Transfusion (product code BRZ), Class II - Special Controls.

Submitted by Arteriocyte Medical Systems, Inc. (Hopkinton, US). The FDA issued a Cleared decision on October 4, 2013 after a review of 18 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arteriocyte Medical Systems, Inc. devices

Submission Details

510(k) Number K132905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2013
Decision Date October 04, 2013
Days to Decision 18 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 129d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code BRZ Set, Blood Transfusion
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.