Cleared Traditional

K254180 - PerfusiX-Imaging

K254180 is an FDA 510(k) clearance for PerfusiX-Imaging, manufactured by LIMIS Development B.V.. The device is a Class 2 Gastroenterology & Urology device with product code OWN cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K254180 · LIMIS Development B.V. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
213d
Days
Class 2
Risk

K254180 is an FDA 510(k) clearance for the PerfusiX-Imaging. Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by LIMIS Development B.V. (Leeuwarden, NL). The FDA issued a Cleared decision on July 24, 2026 after a review of 213 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all LIMIS Development B.V. devices

FDA 510(k) Submission Details - K254180

510(k) Number K254180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2025
Decision Date July 24, 2026
Days to Decision 213 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 130d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWN Device Classification - Class 2, Special Controls

Product Code OWN Confocal Optical Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Collection Of Light Signals For Visualization Of Cellular Microstructures.
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 Gastroenterology & Urology devices follow this clearance model.

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All 43
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