510(k) · Cleared
ClearedModified Palladium Seed Model 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theragenics Corp. · IWI Source, Isotope, Sealed, Gold, Titanium, Platinum
Cleared on Dec 22, 1987 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 50 later devices descend from it.
- Decided
- Dec 22, 1987
- Review
- 29 days
- Class
- Class II
- Product code
- IWI
- Recalls
- None
- Predicates
- 0
50 later devices descend from it, 4 citing it directly.
- This deviceK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- Descendant · cites it directly · 26 of its ownK001070 Radiomed SourceRadiomed Corp. · 2000
- Descendant · 2 generations on · 23 of its ownK013660 GenetraRadiomed Corporation · 2001
- Descendant · 3 generations on · 21 of its ownK022326 Radiomed MarkerRadiomed Corporation · 2003
- Descendant · 4 generations on · 20 of its ownK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
- Descendant · cites it directly · 20 of its ownK982226 Uromed Brachytheraphy Iodine-125 SourcesUromed Corp. · 1999
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K001070Radiomed SourceRadiomed Corp. · 2000 · cites it directly26descendants
- K013660GenetraRadiomed Corporation · 2001 · 2 generations on23descendants
- K022326Radiomed MarkerRadiomed Corporation · 2003 · 3 generations on21descendants
- K031206Radiomed Soft Tissue MarkerRadiomed Corp. · 2003 · 4 generations on20descendants
- K982226Uromed Brachytheraphy Iodine-125 SourcesUromed Corp. · 1999 · cites it directly20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K874787 | Modified Palladium Seed Model 100 | Theragenics Corp. | 1987 | — |
| +1 | K001070 | Radiomed Source | Radiomed Corp. | 2000 | — |
| +2 | K013660 | Genetra | Radiomed Corporation | 2001 | — |
| +3 | K022326 | Radiomed Marker | Radiomed Corporation | 2003 | — |
| +4 | K031206 | Radiomed Soft Tissue Marker | Radiomed Corp. | 2003 | — |
| +1 | K982226 | Uromed Brachytheraphy Iodine-125 Sources | Uromed Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IWI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (50)
See all 504 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?
- Of its descendants, K001070 (Radiomed Corp., 2000) has gone furthest, with 26 descendants of its own.
How does its category compare?
All IWI devicesIWI Source, Isotope, Sealed, Gold, Titanium, Platinum: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IWI
FDA has decided no IWI device since 2007.
Median 510(k) review, days · IWI
Too few IWI 510(k)s in any year since 2007 to give a median.
Recalls per year · IWI
No recall names IWI since 2007.
Adverse event reports per year · IWI
1in 2015
MAUDE reports naming product code IWI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K874787 · printed Nov 4, 2026
Cite this page
510(k) Report. “K874787: Modified Palladium Seed Model 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K874787
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026