510(k) · Cleared
ClearedTheraload Custom Loaded Needles, Models 200 and 125.S06
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theragenics Corp. · KXK Source, Brachytherapy, Radionuclide
Cleared on Jan 26, 2005 as substantially equivalent to K010283 (Theragenics Corp., 2001) and 2 other predicates after a 28-day review. Its family tree reaches back 4 generations to 1980. 9 later devices descend from it.
- Decided
- Jan 26, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K801748 (1980). 15 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK801748 3M I-125 Seeds in Absorbable Carrier3M Company · 1980
- 3 generations backK982226 Uromed Brachytheraphy Iodine-125 SourcesUromed Corp. · 1999
- 2 generations backK021343 Isoseeds I-125Bebig Isotopen-Und Medizintechnik GmbH · 2002
- 1 generation backK040339 Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH · 2004
- This deviceK043596 Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp. · 2005
- Descendant · cites it directly · 7 of its ownK062384 Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK092136 Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Isoray Medical, Inc. · 2009
- Descendant · 3 generations on · 3 of its ownK180515 GammaTileIsoray Medical, Inc. · 2018
- Descendant · 4 generations on · 2 of its ownK190296 GammaTileGt Medical Technologies · 2019
- Descendant · 5 generations on · 1 of its ownK190839 GammaTileGt Medical Technologies · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K062384Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc. · 2006 · cites it directly7descendants
- K092136Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Isoray Medical, Inc. · 2009 · 2 generations on4descendants
- K180515GammaTileIsoray Medical, Inc. · 2018 · 3 generations on3descendants
- K190296GammaTileGt Medical Technologies · 2019 · 4 generations on2descendants
- K190839GammaTileGt Medical Technologies · 2020 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K801748 | 3M I-125 Seeds in Absorbable Carrier | 3M Company | 1980 | — |
| −3 | K982226 | Uromed Brachytheraphy Iodine-125 Sources | Uromed Corp. | 1999 | — |
| −2 | K021343 | Isoseeds I-125 | Bebig Isotopen-Und Medizintechnik GmbH | 2002 | — |
| −1 | K040339 | Brachytherapy Strand Device | Bebig Isotopen-Und Medizintechnik GmbH | 2004 | — |
| 0 (this device) | K043596 | Theraload Custom Loaded Needles, Models 200 and 125.S06 | Theragenics Corp. | 2005 | — |
| +1 | K062384 | Cesium-131 Strand, Strand Preload, Preload, S-Cartridge | Isoray, Inc. | 2006 | — |
| +2 | K092136 | Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5 | Isoray Medical, Inc. | 2009 | — |
| +3 | K180515 | GammaTile | Isoray Medical, Inc. | 2018 | — |
| +4 | K190296 | GammaTile | Gt Medical Technologies | 2019 | — |
| +5 | K190839 | GammaTile | Gt Medical Technologies | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 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? (4)
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 |
|---|---|---|---|
| * | K010283 | Theraseed (R) Palladium-103 Implant; Model 200Summary page 1…uclide Brachytherapy Source (KXK), 21 CFR 892.5730 Device Classification: Class 11 (Radiology) Predicate Devices: TheraSeed, K010283 (2001) I-Seed 1-125, K021343 Brachytherapy Strand Device, K040339 Manu… | 2001 |
| * | K021343 | Isoseeds I-125Summary page 1…892.5730 Device Classification: Class 11 (Radiology) Predicate Devices: TheraSeed, K010283 (2001) I-Seed 1-125, K021343 Brachytherapy Strand Device, K040339 Manufacturer: Theragenics Corporation®… | 2002 |
| * | K040339 | Brachytherapy Strand DeviceSummary page 1…logy) Predicate Devices: TheraSeed, K010283 (2001) I-Seed 1-125, K021343 Brachytherapy Strand Device, K040339 Manufacturer: Theragenics Corporation® 5203 Bristol Industrial Way… | 2004 |
| * | — | TheraStrand Named without a submission number |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K062384 (Isoray, Inc., 2006) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K010283.
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?
TheraLoadTM is a sterile prostate-seeding kit containing TheraSeed® (Pd-103) or I-Seed (I-125) seeds and spacers custom loaded according to the treatment plan.
The brachytherapy source is intended to treat localized, unresectable tumors with low to moderate radiosensitivity. Tumors may be recurrent or residual following external beam or excision of primary tumor and may be superficial, intrathoracic (head, neck, lung), or intra-abdominal (pancreas, prostate).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043596 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043596: Theraload Custom Loaded Needles, Models 200 and 125.S06.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043596
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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