Cleared Traditional

K251037 - Rectal Applicator

K251037 is an FDA 510(k) clearance for Rectal Applicator, manufactured by Nucletron B.V.. The device is a Class 2 Radiology device with product code JAQ cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K251037 · Nucletron B.V. · Radiology device
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Dec 2025
Decision
260d
Days
Class 2
Risk

K251037 is an FDA 510(k) clearance for the Rectal Applicator. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Nucletron B.V. (Veenendaal, NL). The FDA issued a Cleared decision on December 19, 2025 after a review of 260 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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 Nucletron B.V. devices

FDA 510(k) Submission Details - K251037

510(k) Number K251037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2025
Decision Date December 19, 2025
Days to Decision 260 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
153d slower than avg
Panel avg: 107d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAQ Device Classification - Class 2, Special Controls

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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 - JAQ System, Applicator, Radionuclide, Remote-controlled

All 121
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K251037.
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