510(k) · Cleared
ClearedGold Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Naslund Medical AB · IYE Accelerator, Linear, Medical
Cleared on Jun 11, 2020 as substantially equivalent to K160209 (Naslund Medical AB, 2016) after a 45-day review. Its family tree reaches back 8 generations to 1987. 1 later device descends from it.
- Decided
- Jun 11, 2020
- Review
- 45 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K874787 (1987). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 7 generations backK001070 Radiomed SourceRadiomed Corp. · 2000
- 6 generations backK013660 GenetraRadiomed Corporation · 2001
- 5 generations backK022326 Radiomed MarkerRadiomed Corporation · 2003
- 4 generations backK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
- 3 generations backK070305 Pre-Loaded VisicoilRadiomed Corporation · 2007
- 2 generations backK091645 Gold AnchorNaslund Medical AB · 2009
- 1 generation backK160209 Gold AnchorNaslund Medical AB · 2016
- This deviceK201117 Gold AnchorNaslund Medical AB · 2020
- Descendant · cites it directly · 0 of its ownK213053 Gold AnchorNaslund Medical AB · 2022
Most influential descendants
Showing 1 of 1 · See all- K213053Gold AnchorNaslund Medical AB · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K874787 | Modified Palladium Seed Model 100 | Theragenics Corp. | 1987 | — |
| −7 | K001070 | Radiomed Source | Radiomed Corp. | 2000 | — |
| −6 | K013660 | Genetra | Radiomed Corporation | 2001 | — |
| −5 | K022326 | Radiomed Marker | Radiomed Corporation | 2003 | — |
| −4 | K031206 | Radiomed Soft Tissue Marker | Radiomed Corp. | 2003 | — |
| −3 | K070305 | Pre-Loaded Visicoil | Radiomed Corporation | 2007 | — |
| −2 | K091645 | Gold Anchor | Naslund Medical AB | 2009 | — |
| −1 | K160209 | Gold Anchor | Naslund Medical AB | 2016 | — |
| 0 (this device) | K201117 | Gold Anchor | Naslund Medical AB | 2020 | — |
| +1 | K213053 | Gold Anchor | Naslund Medical AB | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K160209 | Gold AnchorSummary page 4…Accelerator, Linear, Medical Regulatory Class: II Product Code: IYE III. PREDICATE DEVICE Predicate device: Gold Anchor, K160209 IV. DEVICE DESCRIPTION The Gold Anchor™ Marker is a fiducial gold marker intended to be implanted within the body, either tempor… | 2016 |
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 |
|---|---|---|---|
| K213053 | Gold Anchor | 2022 | 0 |
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 33 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K213053 (Naslund Medical AB, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The Gold Anchor marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201117: Gold Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201117
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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