Cleared Traditional

K253985 - INNOVANCE® D-Dimer 2.0 (SMN 10873803)

K253985 is an FDA 510(k) clearance for INNOVANCE D-Dimer 2.0 (SMN 10873803), manufactured by Siemens Healthcare Diagnostic Products GmbH. The device is a Class 2 Hematology device with product code DAP cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K253985 · Siemens Healthcare Diagnostic Products GmbH · Hematology device
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Aug 2026
Decision
242d
Days
Class 2
Risk

K253985 is an FDA 510(k) clearance for the INNOVANCE® D-Dimer 2.0 (SMN 10873803). Classified as Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostic Products GmbH (Marburg, DE). The FDA issued a Cleared decision on August 11, 2026 after a review of 242 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7320 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostic Products GmbH devices

FDA 510(k) Submission Details - K253985

510(k) Number K253985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2025
Decision Date August 11, 2026
Days to Decision 242 days
Submission Type Traditional
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
129d slower than avg
Panel avg: 113d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAP Device Classification - Class 2, Special Controls

Product Code DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7320
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 - DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

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