510(k) · Cleared

Cleared

Radiomed Soft Tissue Marker

K031206510(k) SpecialCleared May 21, 200335-day reviewClass II21 CFR 892.1750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Radiomed Corp. · JAK System, X-Ray, Tomography, Computed

Cleared on May 21, 2003 as substantially equivalent to K022326 (Radiomed Corporation, 2003) and 1 other predicate after a 35-day review. Its family tree reaches back 4 generations to 1987. 20 later devices descend from it.

Decided: May 21, 2003
Review: 35 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K874787 (1987). 9 ancestors in all. 20 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 4 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
3 generations backK001070 Radiomed SourceRadiomed Corp. · 2000
2 generations backK013660 GenetraRadiomed Corporation · 2001
1 generation backK022326 Radiomed MarkerRadiomed Corporation · 2003
This deviceK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
Descendant · cites it directly · 11 of its ownK070305 Pre-Loaded VisicoilRadiomed Corporation · 2007
Descendant · cites it directly · 9 of its ownK080726 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008
Descendant · 2 generations on · 6 of its ownK102373 Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010
Descendant · 2 generations on · 4 of its ownK112768 Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011
Descendant · 3 generations on · 3 of its ownK123137 Calypso SystemVarian Medical Systems · 2012

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2007high 5 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 20 · See all

K070305Pre-Loaded VisicoilRadiomed Corporation · 2007 · cites it directly11descendants
K080726Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008 · cites it directly9descendants
K102373Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010 · 2 generations on6descendants
K112768Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011 · 2 generations on4descendants
K123137Calypso SystemVarian Medical Systems · 2012 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K874787	Modified Palladium Seed Model 100	Theragenics Corp.	1987	—
−3	K001070	Radiomed Source	Radiomed Corp.	2000	—
−2	K013660	Genetra	Radiomed Corporation	2001	—
−1	K022326	Radiomed Marker	Radiomed Corporation	2003	—
0 (this device)	K031206	Radiomed Soft Tissue Marker	Radiomed Corp.	2003	—
+1	K070305	Pre-Loaded Visicoil	Radiomed Corporation	2007	—
+1	K080726	Calypso 4D Localization System	Calypso Medical Technologies, Inc.	2008	—
+2	K102373	Calypso System with Dynamic Edge Gating	Calypso Medical Technologies, Inc.	2010	—
+2	K112768	Calypso Systems with Dynamic Edge Gating	Calypso Medical Technologies, Inc.	2011	—
+3	K123137	Calypso System	Varian Medical Systems	2012	—

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
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

FIG. 1 — Lineage of K031206, 1987–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K022326	Radiomed Marker	Radiomed Corporation	2003	—
*	K940121	Implanters/Adjustable/Anderson's Markers Summary page 1 …The predicate devices for RadioMedTM Soft Tissue Marker are: 1. The RadioMedTMMarker, KO22326 2. The Implanter/Adjustable/Anderson’sMarker, K940 12 1 3. The Extracranial Marker (K number unknown) 4. Device Description The RadioMedTM Soft Tissue Marker i…	Best Industries	1994	—
*	—	Extracranial Marker Named without a submission number			—
†	K970278	Microvasive Gold Probe	Boston Scientific Corp	1997	—
†	K010026	Embogold Microsphere	Biosphere Medical, Inc.	2001	—
†	P980001	Nir on TM Ranger TM Premounted Stent System	Boston Scientific Corp	1998	—
†	K011740	Contour Design Gold Eyelid Implant, Model Contour Design (Series 3000)	Meddev Corp.	2001	—

What descends from it? (20)

See all 20

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K070305	Pre-Loaded Visicoil	Radiomed Corporation	2007	11
K080726	Calypso 4D Localization System	Calypso Medical Technologies, Inc.	2008	9
K071673	Onc Solutions Marker, Models 001001 to 001012 and 001021 to 001032	Onc Solutions, Inc.	2007	3
K120796	Superdimension Nitinol/Gold Fiducial Marker	Superdimension, Inc.	2012	1

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 9 ancestors has a recall.
Of its descendants, K070305 (Radiomed Corporation, 2007) has gone furthest, with 11 descendants of its own.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAK

27in 2025

2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007high 200 (2014) · low 27 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAK

17in 2025

2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007high 543 (2018) · low 76 (2007)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?

RadioMed™ Soft Tissue 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/K031206 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031206: Radiomed Soft Tissue Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031206

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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