510(k) · Cleared
ClearedSuperdimension Nitinol/Gold Fiducial Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Superdimension, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 26, 2012 as substantially equivalent to K031206 (Radiomed Corp., 2003) and 2 other predicates after a 225-day review. Its family tree reaches back 5 generations to 1987. 1 later device descends from it.
- Decided
- Oct 26, 2012
- Review
- 225 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K874787 (1987). 19 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 4 generations backK001070 Radiomed SourceRadiomed Corp. · 2000
- 3 generations backK013660 GenetraRadiomed Corporation · 2001
- 2 generations backK022326 Radiomed MarkerRadiomed Corporation · 2003
- 1 generation backK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
- This deviceK120796 Superdimension Nitinol/Gold Fiducial MarkerSuperdimension, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK170570 Anchored Beacon (R) transponder, Anchored transponder, Beacon Care…Varian Medical Systems, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K170570Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package - LungVarian Medical Systems, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K874787 | Modified Palladium Seed Model 100 | Theragenics Corp. | 1987 | — |
| −4 | K001070 | Radiomed Source | Radiomed Corp. | 2000 | — |
| −3 | K013660 | Genetra | Radiomed Corporation | 2001 | — |
| −2 | K022326 | Radiomed Marker | Radiomed Corporation | 2003 | — |
| −1 | K031206 | Radiomed Soft Tissue Marker | Radiomed Corp. | 2003 | — |
| 0 (this device) | K120796 | Superdimension Nitinol/Gold Fiducial Marker | Superdimension, Inc. | 2012 | — |
| +1 | K170570 | Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package -… | Varian Medical Systems, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K031206 | Radiomed Soft Tissue MarkerSummary page 1…l Radiology Regulation/Product Code 21 CFR Part §892.1750 / JAK Legally marketed device(s) to 510(k) K031206 RadioMed Visicoil (JAK 21 CFR §892.1750) which equivalence is claimed 510(k) K100267 Cortex Manufacturing Flex… | 2003 |
| * | K100267 | Fleximarc, Model CM-0.9-2-10-GG-LSummary page 1…1750 / JAK Legally marketed device(s) to 510(k) K031206 RadioMed Visicoil (JAK 21 CFR §892.1750) which equivalence is claimed 510(k) K100267 Cortex Manufacturing Fleximarc lYE 21 CFR §892.5050) 510(k) K093064 Somatex Tumar… | 2010 |
| * | K093064 | Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560Summary page 1…hich equivalence is claimed 510(k) K100267 Cortex Manufacturing Fleximarc lYE 21 CFR §892.5050) 510(k) K093064 Somatex Tumark Professional (NEU 21 CFR §878.4300) Device description The superDimension superLock C… | 2010 |
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 |
|---|---|---|---|
| K170570 | Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package - Lung | 2018 | 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 25 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K170570 (Varian Medical Systems, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K031206.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
The superDimension superLock Cobra is intended for use to radiographically mark soft tissue for future surgical therapeutic procedures.
The superLock Cobra is contraindicated as follows:
- No more than 10 devices should be used per patient
- Devices should not be used in an MRI machine with magnetic coils that exceed 3T
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120796: Superdimension Nitinol/Gold Fiducial Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120796
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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