Cleared Traditional

K251893 - SKAN C PULSAR

K251893 is an FDA 510(k) clearance for SKAN C PULSAR, manufactured by Skanray Technologies Limited. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K251893 · Skanray Technologies Limited · Radiology device
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Dec 2025
Decision
179d
Days
Class 2
Risk

K251893 is an FDA 510(k) clearance for the SKAN C PULSAR. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Skanray Technologies Limited (Mysore, IN). The FDA issued a Cleared decision on December 16, 2025 after a review of 179 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Skanray Technologies Limited devices

FDA 510(k) Submission Details - K251893

510(k) Number K251893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2025
Decision Date December 16, 2025
Days to Decision 179 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 107d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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 Radiology devices follow this clearance model.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 245
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