Cleared Special

K260909 - Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (SCP1)

Also marketed or referenced as:
Sonoclot Coagulation & Platelet Function Analzyer System with Sonoclot Viewer (SCP2) Sonoclot Coagulation Analyzer System with Sonoclot Viewer (SC1)

K260909 is an FDA 510(k) clearance for Sonoclot Coagulation & Platelet Functio..., manufactured by Sienco, Inc.. The device is a Class 2 Hematology device with product code JPA cleared through the Special 510(k) pathway after a 222-day FDA review.

K260909 · Sienco, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
222d
Days
Class 2
Risk

K260909 is an FDA 510(k) clearance for the Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer.... Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Sienco, Inc. (Boulder, US). The FDA issued a Cleared decision on October 27, 2026 after a review of 222 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K260909

510(k) Number K260909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2026
Decision Date October 27, 2026
Days to Decision 222 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 113d · This submission: 222d
Pathway characteristics
Modification to existing cleared device.

JPA Device Classification - Class 2, Special Controls

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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.

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All 181
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K260909 · Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (SCP1)
Download PDF FDA Summary Sienco, Inc.