510(k) · Cleared
ClearedAnchored Beacon (R) transponder, Anchored transponder, Beacon Care Package - Lung
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Apr 6, 2018 as substantially equivalent to K140823 (Varian Medical Systems, Inc., 2014) and 1 other predicate after a 403-day review. Its family tree reaches back 10 generations to 1987. 4 of the 43 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 6, 2018
- Review
- 403 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K874787 (1987). 42 ancestors in all. No later device cites it as a predicate yet. 4 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 6 generations between
- 3 generations backK112768 Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011
- 2 generations backK123137 Calypso SystemVarian Medical Systems · 2012
- 1 generation backK140823 Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc. · 2014
- This deviceK170570 Anchored Beacon (R) transponder, Anchored transponder, Beacon Care…Varian Medical Systems, Inc. · 2018
Show all 10 generations
- Root · 10 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 9 generations backK001070 Radiomed SourceRadiomed Corp. · 2000
- 8 generations backK013660 GenetraRadiomed Corporation · 2001
- 7 generations backK022326 Radiomed MarkerRadiomed Corporation · 2003
- 6 generations backK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
- 5 generations backK080726 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008
- 4 generations backK102373 Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010
- 3 generations backK112768 Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011
- 2 generations backK123137 Calypso SystemVarian Medical Systems · 2012
- 1 generation backK140823 Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc. · 2014
- This deviceK170570 Anchored Beacon (R) transponder, Anchored transponder, Beacon Care…Varian Medical Systems, Inc. · 2018
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K874787 | Modified Palladium Seed Model 100 | Theragenics Corp. | 1987 | — |
| −9 | K001070 | Radiomed Source | Radiomed Corp. | 2000 | — |
| −8 | K013660 | Genetra | Radiomed Corporation | 2001 | — |
| −7 | K022326 | Radiomed Marker | Radiomed Corporation | 2003 | — |
| −6 | K031206 | Radiomed Soft Tissue Marker | Radiomed Corp. | 2003 | — |
| −5 | K080726 | Calypso 4D Localization System | Calypso Medical Technologies, Inc. | 2008 | — |
| −4 | 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 | — |
| −2 | K123137 | Calypso System | Varian Medical Systems | 2012 | — |
| −1 | K140823 | Permanent Beacon Transponder/Soft Tissue Beacon Transponder | Varian Medical Systems, Inc. | 2014 | — |
| 0 (this device) | 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 | 3 | 0 |
| 1996 | 2 | 1 |
| 1997 | 2 | 0 |
| 1998 | 2 | 2 |
| 1999 | 4 | 0 |
| 2000 | 4 | 1 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 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.
4 devices in this family have a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K140823 | Permanent Beacon Transponder/Soft Tissue Beacon TransponderSummary page 4…ed transponder Beacon® Care Package - Lung Fiducial marker Medical charged-particle radiation therapy system CFR 892.5050 Class 11 IYE Permanent Beacon transponder (K140823) The Anchored Beacon® transponder is a small passive implant, intended for permanent implantation in small airways in the lung.… | 2014 |
| * | K120796 | Superdimension Nitinol/Gold Fiducial MarkerSummary page 5…permanently implanted in the lung. The selected predicates are the following fiducial markers: the Soft Tissue Transponder 14G (K140823) and the superlock cobra marker (K120796). A comparison of the similarities and differences of the intended use/indications for use, technology, and other characteristics… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 3 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 42 ancestors have a recall of any class; 4 have a Class I recall.
- 1 other device also cites its predicate K140823.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Calypso System is intended for use as an adjunct in treatment planning and radiation therapy, to align and/or monitor the patient’s position relative to the isocenter of a radiation therapy system. The Calypso System provides accurate, precise, and continuous localization of a treatment isocenter by using two or more Beacon transponders.
Anchored Beacon transponders are indicated for permanent implantation in small airways in the lung to align and/or monitor the internal position of targets that move with respiratory and other patient motion in real time during radiation therapy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170570: Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package - Lung.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170570
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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