Cleared Traditional

K242818 - IsoSphere

K242818 is an FDA 510(k) clearance for IsoSphere, manufactured by Isoaid, LLC. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K242818 · Isoaid, LLC · Radiology device
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Jul 2025
Decision
300d
Days
Class 2
Risk

K242818 is an FDA 510(k) clearance for the IsoSphere. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Isoaid, LLC (Port Richey, US). The FDA issued a Cleared decision on July 15, 2025 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - 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 Isoaid, LLC devices

FDA 510(k) Submission Details - K242818

510(k) Number K242818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2024
Decision Date July 15, 2025
Days to Decision 300 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
193d slower than avg
Panel avg: 107d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXK Device Classification - Class 2, Special Controls

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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 - KXK Source, Brachytherapy, Radionuclide

All 31
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K242818.
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GammaTile
K190839 · Gt Medical Technologies · Jan 2020