510(k) · Cleared
ClearedOnc Solutions Marker, Models 001001 to 001012 and 001021 to 001032
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Onc Solutions, Inc. · IYE Accelerator, Linear, Medical
Cleared on Jul 18, 2007 as substantially equivalent to K031206 (Radiomed Corp., 2003) and 1 other predicate after a 29-day review. Its family tree reaches back 6 generations to 1987. 3 later devices descend from it.
- Decided
- Jul 18, 2007
- Review
- 29 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K874787 (1987). 11 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 5 generations backK001070 Radiomed SourceRadiomed Corp. · 2000
- 4 generations backK013660 GenetraRadiomed Corporation · 2001
- 3 generations backK022326 Radiomed MarkerRadiomed Corporation · 2003
- 2 generations backK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
- 1 generation backK070305 Pre-Loaded VisicoilRadiomed Corporation · 2007
- This deviceK071673 Onc Solutions Marker, Models 001001 to 001012 and 001021 to 001032Onc Solutions, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK140823 Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK170570 Anchored Beacon (R) transponder, Anchored transponder, Beacon Care…Varian Medical Systems, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK152761 Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon…Varian Medical Systems, Inc. · 2015
Most influential descendants
Showing 3 of 3 · See all- K140823Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc. · 2014 · cites it directly2descendants
- K170570Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package - LungVarian Medical Systems, Inc. · 2018 · 2 generations on0descendants
- K152761Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft…Varian Medical Systems, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K874787 | Modified Palladium Seed Model 100 | Theragenics Corp. | 1987 | — |
| −5 | K001070 | Radiomed Source | Radiomed Corp. | 2000 | — |
| −4 | K013660 | Genetra | Radiomed Corporation | 2001 | — |
| −3 | K022326 | Radiomed Marker | Radiomed Corporation | 2003 | — |
| −2 | K031206 | Radiomed Soft Tissue Marker | Radiomed Corp. | 2003 | — |
| −1 | K070305 | Pre-Loaded Visicoil | Radiomed Corporation | 2007 | — |
| 0 (this device) | K071673 | Onc Solutions Marker, Models 001001 to 001012 and 001021 to 001032 | Onc Solutions, Inc. | 2007 | — |
| +1 | K140823 | Permanent Beacon Transponder/Soft Tissue Beacon Transponder | Varian Medical Systems, Inc. | 2014 | — |
| +2 | K170570 | Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package -… | Varian Medical Systems, Inc. | 2018 | — |
| +2 | K152761 | Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care… | Varian Medical Systems, Inc. | 2015 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 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 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? (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…ation Name: Accelerator, Linear, Medical 3. Identification of Predicate or Legally Marketed Device The predicate devices for the ONC Marker are: K031206 RadioMed Soft Tissue Marker K070305 Preloaded RadioMed Soft Tissue Marker 17G, 18G, 19G Introducer Needles manufactured by… | 2003 |
| * | K070305 | Pre-Loaded VisicoilSummary page 1…r, Linear, Medical 3. Identification of Predicate or Legally Marketed Device The predicate devices for the ONC Marker are: K031206 RadioMed Soft Tissue Marker K070305 Preloaded RadioMed Soft Tissue Marker 17G, 18G, 19G Introducer Needles manufactured by CP Medical (Class I - exempt) 4. Devic… | 2007 |
| * | — | 17G, 18G, 19G Introducer Needles manufactured by CP Medical Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140823 | Permanent Beacon Transponder/Soft Tissue Beacon Transponder | 2014 | 2 |
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 20 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K140823 (Varian Medical Systems, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K031206.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
ONC 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/K071673 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071673: Onc Solutions Marker, Models 001001 to 001012 and 001021 to 001032.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071673
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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