510(k) · Cleared
ClearedCivastring PD-103
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 30, 2008 as substantially equivalent to K001070 (Radiomed Corp., 2000) and 2 other predicates after a 61-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it.
- Decided
- Sep 30, 2008
- Review
- 61 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K874787 (1987). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 1 generation backK001070 Radiomed SourceRadiomed Corp. · 2000
- This deviceK082159 Civastring PD-103Civatech Oncology, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK140490 Civa Sheet PD-103Civatech Oncology, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K140490Civa Sheet PD-103Civatech Oncology, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K874787 | Modified Palladium Seed Model 100 | Theragenics Corp. | 1987 | — |
| −1 | K001070 | Radiomed Source | Radiomed Corp. | 2000 | — |
| 0 (this device) | K082159 | Civastring PD-103 | Civatech Oncology, Inc. | 2008 | — |
| +1 | K140490 | Civa Sheet PD-103 | Civatech Oncology, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 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? (3)
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 |
|---|---|---|---|
| * | K001070 | Radiomed Source | 2000 |
| * | K040766 | Optisource, Model 1032PSummary page 1…ing predicate devices: · RadioMedTM Source by RadioMed Corporation, 510(k) KO01070 * OptiSource 1 3 °by International Brachytherapy, Inc., 5 10(k) K040766 · Readi-Strand Model PSStrand by Worldwide Medical Technologies, Inc., 510(k) K023179 4. Device De… | 2004 |
| * | K023179 | Readi-Strand, Model PsstrandSummary page 1…tiSource 1 3 °by International Brachytherapy, Inc., 5 10(k) K040766 · Readi-Strand Model PSStrand by Worldwide Medical Technologies, Inc., 510(k) K023179 4. Device Description: CivaStringPd 1° 3 is a linear LDR (low dose rate) brachytherapy source comprised of… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140490 | Civa Sheet PD-103 | 2014 | 0 |
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 21 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K140490 (Civatech Oncology, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K001070.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
CivaStringPdl° 3 is indicated for use as a permanent interstitial brachytherapy source for the treatment of selected localized tumors. The device may be used either as the primary treatment or for treatment of residual disease after excision of the primary tumor. CivaStringPdl° 3 may be indicated for use concurrently with or sequentially with other treatment modalities, such as external beam radiation therapy or chemotherapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082159: Civastring PD-103.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082159
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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