510(k) · Cleared
ClearedACCUSYTE 3D Fiducial Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiation Products, LLC · IYE Accelerator, Linear, Medical
Cleared on Jul 18, 2018 as substantially equivalent to K071614 (Civco, 2007) and 2 other predicates after a 196-day review. Its family tree reaches back 6 generations to 2001. 1 of the 18 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 18, 2018
- Review
- 196 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K001807 (2001). 17 ancestors in all, the oldest K980704 (1998). No later device cites it as a predicate yet. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK001807 Tissue MarkerAdvanced Uroscience, Inc. · 2001
- 5 generations backK032347 Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 2003
- 4 generations backK042296 Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 2004
- 3 generations backK072913 Securmark Biopsy Site Identification SystemSuros Surgical Systems, Inc. A Hologic Company · 2008
- 2 generations backK113202 Tissue MarkerFocal Therapeutics · 2012
- 1 generation backK143484 BioZorb MarkerFocal Therapeutics · 2015 · Recalled (Class I)
- This deviceK180027 ACCUSYTE 3D Fiducial MarkerRadiation Products, LLC · 2018
Class I recalls in this family
- K143484 BioZorb Markerdirect predicate · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001807 | Tissue Marker | Advanced Uroscience, Inc. | 2001 | — |
| −5 | K032347 | Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | 2003 | — |
| −4 | K042296 | Biomarc Preloaded Tissue Marker Device | Carbon Medical Technologies, Inc. | 2004 | — |
| −3 | K072913 | Securmark Biopsy Site Identification System | Suros Surgical Systems, Inc. A Hologic Company | 2008 | — |
| −2 | K113202 | Tissue Marker | Focal Therapeutics | 2012 | — |
| −1 | K143484 | BioZorb Marker | Focal Therapeutics | 2015 | Class I |
| 0 (this device) | K180027 | ACCUSYTE 3D Fiducial Marker | Radiation Products, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K071614 | Fiducial MarkersSummary page 4…l charged-particle radiation therapy system Classification Number: 892.5050 Device Classification: Class II Product Code: IYE Predicate Device: CIVCO Suture-Type Marker (K071614) Reference Devices: BioZorb Marker (K143484) Foosin WEGO-PGLA Absorbable Suture (K130735) Substantiall… | 2007 |
| * | K143484 | BioZorb MarkerSummary page 4…Classification Number: 892.5050 Device Classification: Class II Product Code: IYE Predicate Device: CIVCO Suture-Type Marker (K071614) Reference Devices: BioZorb Marker (K143484) Foosin WEGO-PGLA Absorbable Suture (K130735) Substantially Equivalent to: The ACCUSYTE™ 3D Fiducial M… | 2015 |
| * | K130735 | Synthetic Absorbable SutureSummary page 4…Code: IYE Predicate Device: CIVCO Suture-Type Marker (K071614) Reference Devices: BioZorb Marker (K143484) Foosin WEGO-PGLA Absorbable Suture (K130735) Substantially Equivalent to: The ACCUSYTE™ 3D Fiducial Marker is substantially equivalent in intended use, principle of operati… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K143484BioZorb MarkerFocal Therapeutics · 2015 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
- 10 other devices also cite its predicate K071614.
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 ACCUSYTE™ 3D Fiducial Markers are used to mark the location of a tumor cavity after the tumor has been removed.
In addition, the Markers are indicated on situations where soft tissue needs to be marked for future medical procedure such as subsequent Radiation Therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180027: ACCUSYTE 3D 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/K180027
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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