Cleared Special

K002528 - SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION (FDA 510(k) Clearance)

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

K002528 · Sienco, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
15d
Days
Class 2
Risk

K002528 is an FDA 510(k) clearance for the SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWE.... 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 August 31, 2000 after a review of 15 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. 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 Sienco, Inc. devices

Submission Details

510(k) Number K002528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2000
Decision Date August 31, 2000
Days to Decision 15 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 113d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.