510(k) · Cleared
ClearedCivaDerm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Civatech Oncology, Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on Sep 20, 2019 as substantially equivalent to K090321 (Ri Consultants, LLC, 2009) after a 127-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Sep 20, 2019
- Review
- 127 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931393 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 KXK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KXK device
- #1 K242818 IsoSpherescore 10.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K090321 | Ric Conformal Source, Model 100Summary page 4…91324 5. Identification of devices to which the submitted claims equivalence: Device Name: RIC Conformal Source Model 100 Brachytherapy Source 510K Number: K090321 Classification: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Produ… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 15.2 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K090321.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KXK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KXK
158in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KXK
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KXK
7in 2025
MAUDE reports naming product code KXK, 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 | 5 | 42 | 0 | 9 |
| 2008 | 1 | — | 1 | 15 |
| 2009 | 7 | 63 | 0 | 10 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 5 | 94 | 1 | 35 |
| 2012 | 3 | 109 | 1 | 4 |
| 2013 | 3 | 127 | 0 | 29 |
| 2014 | 8 | 96 | 0 | 13 |
| 2015 | 2 | — | 0 | 6 |
| 2016 | 4 | 49 | 1 | 40 |
| 2017 | 2 | — | 0 | 41 |
| 2018 | 1 | — | 0 | 28 |
| 2019 | 2 | — | 0 | 10 |
| 2020 | 3 | 158 | 0 | 15 |
| 2021 | 0 | — | 0 | 62 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 2 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CivaDermPd103 indicated for treatment of temporary intraoperative or surface application to treat selected localized tumors. It can 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191324: CivaDerm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191324
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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