510(k) · Cleared
ClearedRapid Strand RX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi-Physics, Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on Dec 28, 2012 as substantially equivalent to K063177 (Oncura, Inc., 2006) after a 109-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Dec 28, 2012
- Review
- 109 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010621 (2001). 7 ancestors in all, the oldest K914281 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK010621 Accu-Space Absorbable Seeding SpacersCp Medical · 2001
- 3 generations backK013964 Modification to Accu-Space Plain Gut Absorbable Seeding SpacersCp Medical · 2002
- 2 generations backK030594 I-125 Rapid Strand, Model 7000Amersham Health · 2003
- 1 generation backK063177 Rapid Strand RXOncura, Inc. · 2006 · Recalled
- This deviceK122764 Rapid Strand RXMedi-Physics, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010621 | Accu-Space Absorbable Seeding Spacers | Cp Medical | 2001 | — |
| −3 | K013964 | Modification to Accu-Space Plain Gut Absorbable Seeding Spacers | Cp Medical | 2002 | — |
| −2 | K030594 | I-125 Rapid Strand, Model 7000 | Amersham Health | 2003 | — |
| −1 | K063177 | Rapid Strand RX | Oncura, Inc. | 2006 | 1 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K063177 | Rapid Strand RXSummary page 1…CFR 892.5730). 4. Predicate Device Medi-Physics Inc. RAPID Strand Rx This 510(k), K063 177, received FDA clearance on November 30, 2006. 5. Device Desc… | 2006 |
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 11 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 7 ancestors have a recall of any class.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
RAPID Strand Rx is indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor.
RAPID Strand 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/K122764 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122764: Rapid Strand RX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122764
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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