Cleared Traditional

K032952 - AIACT KIT

K032952 is an FDA 510(k) clearance for AIACT KIT, manufactured by Sienco, Inc.. The device is a Class 2 Hematology device with product code JBP cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K032952 · Sienco, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Dec 2003
Decision
81d
Days
Class 2
Risk

K032952 is an FDA 510(k) clearance for the AIACT KIT. Classified as Activated Whole Blood Clotting Time (product code JBP), Class II - Special Controls.

Submitted by Sienco, Inc. (Boulder, US). The FDA issued a Cleared decision on December 12, 2003 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7140 - the FDA hematology 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 Sienco, Inc. devices

FDA 510(k) Submission Details - K032952

510(k) Number K032952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date December 12, 2003
Days to Decision 81 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 113d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JBP Device Classification - Class 2, Special Controls

Product Code JBP Activated Whole Blood Clotting Time
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7140
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 Hematology devices follow this clearance model.

Regulatory Peers - JBP Activated Whole Blood Clotting Time

All 9
Devices cleared under the same product code (JBP) and FDA review panel - the closest regulatory comparables to K032952.
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K960749 · International Technidyne Corp. · Aug 1996
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K941007 · International Technidyne Corp. · Jun 1994