Cleared Traditional

K232250 - SurgiCount+ System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232250 · Stryker Instruments · General & Plastic Surgery device
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Jan 2024
Decision
167d
Days
Class 2
Risk

K232250 is an FDA 510(k) clearance for the SurgiCount+ System. Classified as Image Processing Device For Estimation Of External Blood Loss (product code PBZ), Class II - Special Controls.

Submitted by Stryker Instruments (Portage, US). The FDA issued a Cleared decision on January 11, 2024 after a review of 167 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.2750 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K232250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2023
Decision Date January 11, 2024
Days to Decision 167 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 114d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PBZ Image Processing Device For Estimation Of External Blood Loss
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2750
Definition An Image Processing Device For Estimation Of External Blood Loss Is A Device To Be Used As An Aid In Estimation Of Patient External Blood Loss. The Device May Include Software And/or Hardware That Is Used To Process Images Capturing Externally Lost Blood To Estimate The Hemoglobin Mass And/or The Blood Volume Present In The Images.
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 General & Plastic Surgery devices follow this clearance model.