Cleared Traditional

K252133 - Adaptix Ortho350 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252133 · Adaptix Limited · Radiology device
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Nov 2025
Decision
122d
Days
Class 2
Risk

K252133 is an FDA 510(k) clearance for the Adaptix Ortho350. Classified as System, X-ray, Tomographic (product code IZF), Class II - Special Controls.

Submitted by Adaptix Limited (Oxford, GB). The FDA issued a Cleared decision on November 6, 2025 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1740 - 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 Adaptix Limited devices

Submission Details

510(k) Number K252133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2025
Decision Date November 06, 2025
Days to Decision 122 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 107d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IZF System, X-ray, Tomographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1740
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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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