510(k) · Cleared
ClearedTrilogy Tissue Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inrad, Inc. · NEU Marker, Radiographic, Implantable
Cleared on Nov 7, 2024 as substantially equivalent to K183503 (Inrad, Inc., 2019) after a 268-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Nov 7, 2024
- Review
- 268 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970817 (1997). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 NEU? 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 NEU device
- #1 K240042 MOLLI 2 Systemscore 14.4 · 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? (1)
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 |
|---|---|---|---|
| * | K183503 | EasyMark Tissue MarkerSummary page 5…REDICATE DEVICE The INRAD, Inc. Trilogy Tissue Marker [subject device] is substantially equivalent (SE) to the Sponsor’s own predicate device: EasyMark™ Tissue Marker, K183503 This predicate device has not been subject to a design related recall. Reference Device: SelectCore Biopsy Device, K093256 This… | 2019 |
| † | K093256 | Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018 | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · NEU
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEU
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEU
2in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NEU
411in 2025
MAUDE reports naming product code NEU, 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 | 4 | 94 | 0 | 5 |
| 2008 | 7 | 107 | 0 | 5 |
| 2009 | 4 | 70 | 0 | 30 |
| 2010 | 5 | 69 | 0 | 12 |
| 2011 | 3 | 145 | 1 | 18 |
| 2012 | 3 | 120 | 0 | 54 |
| 2013 | 7 | 49 | 0 | 60 |
| 2014 | 3 | 48 | 0 | 38 |
| 2015 | 7 | 111 | 0 | 120 |
| 2016 | 2 | — | 0 | 56 |
| 2017 | 4 | 115 | 1 | 69 |
| 2018 | 8 | 89 | 0 | 66 |
| 2019 | 5 | 149 | 0 | 58 |
| 2020 | 3 | 169 | 0 | 45 |
| 2021 | 3 | 46 | 0 | 82 |
| 2022 | 2 | — | 1 | 100 |
| 2023 | 4 | 136 | 0 | 142 |
| 2024 | 10 | 267 | 2 (1) | 247 |
| 2025 | 5 | 99 | 2 | 411 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The Trilogy Tissue Marker is intended for use to attach to breast tissue at the surgical site during an open surgical breast biopsy or percutaneous breast biopsy to radiographically mark the location of the biopsy procedure, and be permanently visible under MRI, x-ray and ultrasound.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240429 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240429: Trilogy 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/K240429
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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