510(k) · Cleared
ClearedBeacon Fine Needle Fiducial System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · NEU Marker, Radiographic, Implantable
Cleared on Dec 30, 2015 as substantially equivalent to K150891 (Covidien, LLC ( Formerly Beacon Endoscopic Corp.), 2015) after a 111-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Dec 30, 2015
- Review
- 111 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K935844 (1995). 22 ancestors in all, the oldest K904667 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 5 generations between
- 3 generations backK133008 BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19…Beacon Endoscopic · 2013
- 2 generations backK141894 Sharkcore Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2014
- 1 generation backK150891 BNX Fine Needle Aspiration System and SharkCore LG Fine Needle…Covidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2015
- This deviceK152586 Beacon Fine Needle Fiducial SystemCovidien, LLC · 2015
Show all 9 generations
- Root · 9 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 8 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 7 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- 6 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- 5 generations backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- 4 generations backK103668 BNX Fine Needle Aspiration SystemBoston Endoscopic Engineering · 2010 · Recalled
- 3 generations backK133008 BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19…Beacon Endoscopic · 2013
- 2 generations backK141894 Sharkcore Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2014
- 1 generation backK150891 BNX Fine Needle Aspiration System and SharkCore LG Fine Needle…Covidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2015
- This deviceK152586 Beacon Fine Needle Fiducial SystemCovidien, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −8 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −7 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| −6 | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| −5 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| −4 | K103668 | BNX Fine Needle Aspiration System | Boston Endoscopic Engineering | 2010 | 5 |
| −3 | K133008 | BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25… | Beacon Endoscopic | 2013 | — |
| −2 | K141894 | Sharkcore Fine Needle Biopsy System | Covidien, LLC ( Formerly Beacon Endoscopic Corp.) | 2014 | — |
| −1 | K150891 | BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System | Covidien, LLC ( Formerly Beacon Endoscopic Corp.) | 2015 | — |
| 0 (this device) | K152586 | Beacon Fine Needle Fiducial System | Covidien, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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.
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 |
|---|---|---|---|
| * | K150891 | BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemSummary page 4…Operator Number Establishment Registration Number: 3004904811 Owner/Operator Number: 1282497 Predicate Device(s) BNX Fine Needle Aspiration (FNA) System (cleared under K150891 on 5/1/15) Device Description The Beacon™ Fine Needle Fiducial System is a sterile, single-use, endoscopic ultrasound device whi… | 2015 |
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 20 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 22 ancestors have a recall of any class.
- 1 other device also cites its predicate K150891.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Beacon Fine Needle Fiducial System is intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures. The needle is designed with a passive (i.e. automatic) safety shielding feature to aid in the prevention of needle stick injury.
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/K152586 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152586: Beacon Fine Needle Fiducial System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152586
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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