510(k) · Cleared
ClearedRic Conformal Source, Model 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ri Consultants, LLC · ONL Conformal Brachytherapy Source
Cleared on May 27, 2009 as substantially equivalent to K931393 (Bebig, Inc., 1994) after a 107-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- May 27, 2009
- Review
- 107 days
- Class
- Class II
- Product code
- ONL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931393 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK931393 Bebig Plaques RUM101-RUM114Bebig, Inc. · 1994
- This deviceK090321 Ric Conformal Source, Model 100Ri Consultants, LLC · 2009
- Descendant · cites it directly · 0 of its ownK252296 OncoPatchOncopatch, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK191324 CivaDermCivatech Oncology, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931393 | Bebig Plaques RUM101-RUM114 | Bebig, Inc. | 1994 | — |
| 0 (this device) | K090321 | Ric Conformal Source, Model 100 | Ri Consultants, LLC | 2009 | — |
| +1 | K252296 | OncoPatch | Oncopatch, Inc. | 2025 | — |
| +1 | K191324 | CivaDerm | Civatech Oncology, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ONL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K931393 | Bebig Plaques RUM101-RUM114Summary page 2…cal Characteristics: RIC Conformal Source Model 100 Brachytherapy Source is similar to the predicate brachytherapy source, BEBIG Plaques RUM101-RUM114, K931393 dated 16 March 1994, and New England Nuclear 9"Strontium NB-1 Eye Applicator, Pre-Amendment Device, that utiliz… | 1994 |
| * | — | New England Nuclear 90Strontium NB-1 Eye Applicator Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K252296 (Oncopatch, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ONL devicesONL Conformal Brachytherapy Source: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ONL
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · ONL
Too few ONL 510(k)s in any year since 2007 to give a median.
Recalls per year · ONL
No recall names ONL since 2007.
Adverse event reports per year · ONL
1in 2018
MAUDE reports naming product code ONL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (98 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090321: Ric Conformal Source, Model 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090321
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026