510(k) · Cleared
ClearedBest Strand and Best Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Best Medical International, Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on Aug 4, 2006 as substantially equivalent to K034062 (Cp Medical, 2004) and 2 other predicates after a 53-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Aug 4, 2006
- Review
- 53 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K010621 (2001). 7 ancestors in all, the oldest K940632 (1994). 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 backK021311 Synthetic Absorbable Seeding Spacers Made of Polydioxanone MaterialCp Medical · 2002
- 1 generation backK034062 CP Sleeve and River SleeveCp Medical · 2004
- This deviceK061638 Best Strand and Best SpacerBest Medical International, Inc. · 2006
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 | K021311 | Synthetic Absorbable Seeding Spacers Made of Polydioxanone Material | Cp Medical | 2002 | — |
| −1 | K034062 | CP Sleeve and River Sleeve | Cp Medical | 2004 | — |
| 0 (this device) | K061638 | Best Strand and Best Spacer | Best Medical International, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 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? (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 |
|---|---|---|---|
| * | K034062 | CP Sleeve and River SleeveSummary page 1…June 8, 2006 Predicate Device: The predicate device to the Best Medical, Best Strand accessory device is the CP Medical CARRIER SLEEVE accessory device (K034062), and the I- 125 Rapid Strand's accessory Sleeve (K940632 and K010821). Device Description: The Best Medical International, Inc,… | 2004 |
| * | K940632 | I-125 Rapid StrandSummary page 1…ate device to the Best Medical, Best Strand accessory device is the CP Medical CARRIER SLEEVE accessory device (K034062), and the I- 125 Rapid Strand's accessory Sleeve (K940632 and K010821). Device Description: The Best Medical International, Inc, Best Strand consists of synthetic absorbable polymer or c… | 1994 |
| * | K010821 | Echoseed/Iodine-125 Seeds, Model 6733Summary page 1…o the Best Medical, Best Strand accessory device is the CP Medical CARRIER SLEEVE accessory device (K034062), and the I- 125 Rapid Strand's accessory Sleeve (K940632 and K010821). Device Description: The Best Medical International, Inc, Best Strand consists of synthetic absorbable polymer or copolymer mat… | 2001 |
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 5 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K034062.
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?
The Best Medical International, Inc Best Strand component device is indicated for use as an accessory in brachytherapy procedures. It is supplied sterile, as a single-use device. The Best Strand is indicated for use in soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures.
The Best Medical International, Inc., "Best Spacer" device is intended to be used to maintain a predetermined space between radionuclide seeds during the introduction of the seeds into the body during Brachytherapy procedures. Absorbable spacers are indicated for use in soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061638 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061638: Best Strand and Best Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061638
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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