Cleared Special

K223635 - Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (FDA 510(k) Clearance)

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

K223635 · Sienco, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
30d
Days
Class 2
Risk

K223635 is an FDA 510(k) clearance for the Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer. 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 January 4, 2023 after a review of 30 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 K223635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2022
Decision Date January 04, 2023
Days to Decision 30 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
83d faster than avg
Panel avg: 113d · This submission: 30d
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.