# K252296: OncoPatch

- Pathway: 510(k) (Traditional)
- Applicant: Oncopatch, Inc.
- Decided: Dec 5, 2025 after 135 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931393 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090321: Ric Conformal Source, Model 100, Ri Consultants, LLC (2009) Summary page 5.

## Indications for use
OncoPatch is indicated for the surface treatment of localized tumors. It is designed to deliver radiation therapy for the treatment of superficial lesions. It can be used either as primary treatment or as treatment for residual disease after excision of primary or recurrent tumors.

Source page: https://510kreport.com/device/K252296
Methodology: https://510kreport.com/methodology