510(k) · Cleared
Recalled · Class II · 2020Beacon EUS Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · FCG Biopsy Needle
Cleared on Apr 26, 2018 as substantially equivalent to K142198 (Covidien, LLC, 2014) and 1 other predicate after a 111-day review. Its family tree reaches back 8 generations to 1995. It has been recalled 2 times.
- Decided
- Apr 26, 2018
- Review
- 111 days
- Class
- Class II
- Product code
- FCG
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 8 generations to K935844 (1995). 26 ancestors in all, the oldest K904667 (1990). No later device cites it as a predicate yet.
- Root · 8 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 7 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 6 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- 5 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- 4 generations backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- 3 generations backK103668 BNX Fine Needle Aspiration SystemBoston Endoscopic Engineering · 2010 · Recalled
- 2 generations backK133008 BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19…Beacon Endoscopic · 2013
- 1 generation backK142198 BNX Fine Needle Aspiration SystemCovidien, LLC · 2014
- This deviceK180037 Beacon EUS Access SystemCovidien, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −7 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −6 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| −5 | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| −4 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| −3 | K103668 | BNX Fine Needle Aspiration System | Boston Endoscopic Engineering | 2010 | 5 |
| −2 | K133008 | BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25… | Beacon Endoscopic | 2013 | — |
| −1 | K142198 | BNX Fine Needle Aspiration System | Covidien, LLC | 2014 | — |
| 0 (this device) | K180037 | Beacon EUS Access System | Covidien, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 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.
Planning a device in FCG? 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 FCG device
- #1 K250994 ClearTip FNA and FNB Typesscore 13.2 · 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? (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 |
|---|---|---|---|
| * | K142198 | BNX Fine Needle Aspiration SystemSummary page 4…uct Code: FCG Establishment Registration Number, Owner/Operator Number: Establishment Registration Number: 3004904811 Owner/Operator Number: 1282497 Predicate Devices: K142198 BNX FNA System by Covidien llc K092359 EchoTip Ultra HD Ultrasound Access Needle by Cook Ireland Ltd Device Description: The Be… | 2014 |
| * | K092359 | Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19ASummary page 4…on Number, Owner/Operator Number: Establishment Registration Number: 3004904811 Owner/Operator Number: 1282497 Predicate Devices: K142198 BNX FNA System by Covidien llc K092359 EchoTip Ultra HD Ultrasound Access Needle by Cook Ireland Ltd Device Description: The Beacon™ EUS Access System is a sterile, s… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2020 | Class II | Z-2769-2020 | Under Investigation by firm | This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a… |
| Jun 26, 2020 | Class II | Z-2768-2020 | Under Investigation by firm | This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 6 of the 26 ancestors have a recall of any class.
- 1 other device also cites its predicate K142198.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FCG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FCG
82in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FCG
5in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCG
632in 2025
MAUDE reports naming product code FCG, 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 | 32 | 0 | 11 |
| 2008 | 1 | — | 19 | 115 |
| 2009 | 4 | 87 | 5 | 270 |
| 2010 | 3 | 18 | 4 | 73 |
| 2011 | 1 | — | 2 | 71 |
| 2012 | 0 | — | 0 | 107 |
| 2013 | 1 | — | 0 | 130 |
| 2014 | 5 | 88 | 0 | 154 |
| 2015 | 4 | 91 | 0 | 124 |
| 2016 | 3 | 63 | 0 | 191 |
| 2017 | 3 | 166 | 0 | 273 |
| 2018 | 6 | 140 | 0 | 282 |
| 2019 | 0 | — | 0 | 229 |
| 2020 | 1 | — | 0 | 240 |
| 2021 | 1 | — | 5 | 290 |
| 2022 | 2 | — | 0 | 302 |
| 2023 | 4 | 82 | 0 | 428 |
| 2024 | 1 | — | 0 | 446 |
| 2025 | 2 | — | 0 | 632 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Beacon EUS Access System is used to access the following areas of the gastrointestinal tract: the intra- or extra-hepatic bile ducts, pancreatic ducts, cystic duct, gallbladder or for delivery of injectable materials into tissues through the accessory channel of an ultrasound endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180037: Beacon EUS Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180037
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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