Cleared Traditional

K220539 - Klarity SRS Baseplate, Klarity Promise Baseplate (FDA 510(k) Clearance)

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

K220539 · Klarity Medical & Equipment (GZ) Co., Ltd. · Radiology device
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Nov 2022
Decision
249d
Days
Class 2
Risk

K220539 is an FDA 510(k) clearance for the Klarity SRS Baseplate, Klarity Promise Baseplate. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Klarity Medical & Equipment (GZ) Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on November 1, 2022 after a review of 249 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Klarity Medical & Equipment (GZ) Co., Ltd. devices

Submission Details

510(k) Number K220539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2022
Decision Date November 01, 2022
Days to Decision 249 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 107d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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

Klarity Medical Products, LLC
Peter Larson

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.

Regulatory Peers - IYE Accelerator, Linear, Medical

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