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 Jan 6, 2022 as substantially equivalent to K201117 (Naslund Medical AB, 2020) after a 106-day review. Its family tree reaches back 9 generations to 1987.
- Decided
- Jan 6, 2022
- Review
- 106 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K874787 (1987). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 5 generations between
- 3 generations backK091645 Gold AnchorNaslund Medical AB · 2009
- 2 generations backK160209 Gold AnchorNaslund Medical AB · 2016
- 1 generation backK201117 Gold AnchorNaslund Medical AB · 2020
- This deviceK213053 Gold AnchorNaslund Medical AB · 2022
Show all 9 generations
- Root · 9 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 8 generations backK001070 Radiomed SourceRadiomed Corp. · 2000
- 7 generations backK013660 GenetraRadiomed Corporation · 2001
- 6 generations backK022326 Radiomed MarkerRadiomed Corporation · 2003
- 5 generations backK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
- 4 generations backK070305 Pre-Loaded VisicoilRadiomed Corporation · 2007
- 3 generations backK091645 Gold AnchorNaslund Medical AB · 2009
- 2 generations backK160209 Gold AnchorNaslund Medical AB · 2016
- 1 generation backK201117 Gold AnchorNaslund Medical AB · 2020
- This deviceK213053 Gold AnchorNaslund Medical AB · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K874787 | Modified Palladium Seed Model 100 | Theragenics Corp. | 1987 | — |
| −8 | K001070 | Radiomed Source | Radiomed Corp. | 2000 | — |
| −7 | K013660 | Genetra | Radiomed Corporation | 2001 | — |
| −6 | K022326 | Radiomed Marker | Radiomed Corporation | 2003 | — |
| −5 | K031206 | Radiomed Soft Tissue Marker | Radiomed Corp. | 2003 | — |
| −4 | K070305 | Pre-Loaded Visicoil | Radiomed Corporation | 2007 | — |
| −3 | K091645 | Gold Anchor | Naslund Medical AB | 2009 | — |
| −2 | K160209 | Gold Anchor | Naslund Medical AB | 2016 | — |
| −1 | K201117 | Gold Anchor | Naslund Medical AB | 2020 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K201117 | Gold AnchorSummary page 4…Accelerator, Linear, Medical Regulatory Class: II Product Code: IYE III. PREDICATE DEVICE Predicate device: Gold Anchor, K201117 IV. DEVICE DESCRIPTION The Gold Anchor marker is a fiducial gold marker intended to be implanted within the body, either tempora… | 2020 |
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 35 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 14 ancestors has a recall.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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/K213053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213053: 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/K213053
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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