510(k) · Cleared
Recalled · 2011Rapid Strand RX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oncura, Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on Nov 30, 2006 as substantially equivalent to K030594 (Amersham Health, 2003) and 1 other predicate after a 42-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 30, 2006
- Review
- 42 days
- Class
- Class II
- Product code
- KXK
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010621 (2001). 6 ancestors in all, the oldest K914281 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK010621 Accu-Space Absorbable Seeding SpacersCp Medical · 2001
- 2 generations backK013964 Modification to Accu-Space Plain Gut Absorbable Seeding SpacersCp Medical · 2002
- 1 generation backK030594 I-125 Rapid Strand, Model 7000Amersham Health · 2003
- This deviceK063177 Rapid Strand RXOncura, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK122764 Rapid Strand RXMedi-Physics, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K122764Rapid Strand RXMedi-Physics, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010621 | Accu-Space Absorbable Seeding Spacers | Cp Medical | 2001 | — |
| −2 | K013964 | Modification to Accu-Space Plain Gut Absorbable Seeding Spacers | Cp Medical | 2002 | — |
| −1 | K030594 | I-125 Rapid Strand, Model 7000 | Amersham Health | 2003 | — |
| 0 (this device) | K063177 | Rapid Strand RX | Oncura, Inc. | 2006 | — |
| +1 | K122764 | Rapid Strand RX | Medi-Physics, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (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 |
|---|---|---|---|
| * | K030594 | I-125 Rapid Strand, Model 7000Summary page 1…II Classification: 21 CFR 892.5730 Product Code. 90-KXK Cleared in 510(k).: K030594 and K940632 Owner/Holder: Medi-Physics, Inc., Arlington Heights, IL… | 2003 |
| * | K940632 | I-125 Rapid StrandSummary page 1…II Classification: 21 CFR 892.5730 Product Code. 90-KXK Cleared in 510(k).: K030594 and K940632 Owner/Holder: Medi-Physics, Inc., Arlington Heights, IL… | 1994 |
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 |
|---|---|---|---|
| K122764 | Rapid Strand RX | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 20, 2011 | Not classified | Z-0266-2012 | Process control | There is a potential brachytherapy over or under dose with the RAPID Strand Rx kit that may impact patient therapy. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K122764 (Medi-Physics, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K030594.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
RAPID Strand TM Rx is indicated for permanent interstitial implantation of selected localized tumors, which are low to moderate radio sensitivity. They may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor.
RAPID StrandTM Rx may be indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063177 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063177: Rapid Strand RX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063177
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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