510(k) · Cleared
ClearedRadiomed Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiomed Corporation · JAK System, X-Ray, Tomography, Computed
Cleared on Jan 31, 2003 as substantially equivalent to K983400 (United States Surgical, A Division of Tyco Healthc, 1999) and 2 other predicates after a 197-day review. Its family tree reaches back 3 generations to 1987. 21 later devices descend from it.
- Decided
- Jan 31, 2003
- Review
- 197 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K874787 (1987). 7 ancestors in all. 21 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 2 generations backK001070 Radiomed SourceRadiomed Corp. · 2000
- 1 generation backK013660 GenetraRadiomed Corporation · 2001
- This deviceK022326 Radiomed MarkerRadiomed Corporation · 2003
- Descendant · cites it directly · 20 of its ownK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
- Descendant · 2 generations on · 11 of its ownK070305 Pre-Loaded VisicoilRadiomed Corporation · 2007
- Descendant · 2 generations on · 9 of its ownK080726 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008
- Descendant · 3 generations on · 6 of its ownK102373 Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010
- Descendant · 3 generations on · 4 of its ownK112768 Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K031206Radiomed Soft Tissue MarkerRadiomed Corp. · 2003 · cites it directly20descendants
- K070305Pre-Loaded VisicoilRadiomed Corporation · 2007 · 2 generations on11descendants
- K080726Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008 · 2 generations on9descendants
- K102373Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010 · 3 generations on6descendants
- K112768Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K874787 | Modified Palladium Seed Model 100 | Theragenics Corp. | 1987 | — |
| −2 | K001070 | Radiomed Source | Radiomed Corp. | 2000 | — |
| −1 | K013660 | Genetra | Radiomed Corporation | 2001 | — |
| 0 (this device) | K022326 | Radiomed Marker | Radiomed Corporation | 2003 | — |
| +1 | K031206 | Radiomed Soft Tissue Marker | Radiomed Corp. | 2003 | — |
| +2 | K070305 | Pre-Loaded Visicoil | Radiomed Corporation | 2007 | — |
| +2 | K080726 | Calypso 4D Localization System | Calypso Medical Technologies, Inc. | 2008 | — |
| +3 | K102373 | Calypso System with Dynamic Edge Gating | Calypso Medical Technologies, Inc. | 2010 | — |
| +3 | K112768 | Calypso Systems with Dynamic Edge Gating | Calypso Medical Technologies, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 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 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 |
|---|---|---|---|
| * | K983400 | Auto Suture Site Marker ClipSummary page 1…ate of Legally Marketed Device The predicate devices for the RadioMedTMMarker are: United States Sur ical Auto Suture Site Marker Staple, IC983400 Senom Gel MarkEM Biopsy Site Marker, KO00060 GenetraTMSource, KO 13660 4. Device Description… | 1999 |
| * | K000060 | Gel Mark Biopsy Site Marker, Models MKOOO1, MK0004, MK0007 | 2000 |
| * | K013660 | Genetra | 2001 |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031206 | Radiomed Soft Tissue Marker | 2003 | 20 |
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 16 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K031206 (Radiomed Corp., 2003) has gone furthest, with 20 descendants of its own.
- 1 other device also cites its predicate K983400.
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.
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?
RadioMedTMMarker 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/K022326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022326: Radiomed Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022326
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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