# K090321: Ric Conformal Source, Model 100

- Pathway: 510(k) (Traditional)
- Applicant: Ri Consultants, LLC
- Decided: May 27, 2009 after 107 days
- Product code: ONL (Conformal Brachytherapy Source)
- 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: 1 generation back to K931393 (1994). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931393: Bebig Plaques RUM101-RUM114, Bebig, Inc. (1994) Summary page 2.
- (no number) New England Nuclear 90Strontium NB-1 Eye Applicator: named in the summary without a submission number

## Most influential descendants
- K252296: OncoPatch (2025), 0 descendants of its own
- K191324: CivaDerm (2019), 0 descendants of its own

## Indications for use
RIC Conformal Source Model 100 Brachytherapy Source, containing 32Phosphorus with activity up to 200 mCi is indicated for treatment of temporary intraoperative, interstitial, intracavitary or surface application to treat selected localized tumors. Itcan be used either as primary treatment or as treatment for residual disease after excision of primary or recurrent tumors. This brachytherapy source may be used concurrently with or following treatment with other interventions, such as external beam therapy. Chordomas, chondrosarcomas, soft tissue sarcomas, skin cancers and other accessible tumors could be commonly treated by the RIC Conformal Source Model 100 Brachytherapy Source, containing 32 Phosphorus.

Source page: https://510kreport.com/device/K090321
Methodology: https://510kreport.com/methodology