510(k) · Cleared
ClearedBNX Fine Needle Aspiration 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 Oct 8, 2014 as substantially equivalent to K133008 (Beacon Endoscopic, 2013) and 1 other predicate after a 58-day review. Its family tree reaches back 7 generations to 1995. 5 later devices descend from it.
- Decided
- Oct 8, 2014
- Review
- 58 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K935844 (1995). 19 ancestors in all, the oldest K904667 (1990). 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 6 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 5 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- 4 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- 3 generations backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- 2 generations backK103668 BNX Fine Needle Aspiration SystemBoston Endoscopic Engineering · 2010 · Recalled
- 1 generation backK133008 BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19…Beacon Endoscopic · 2013
- This deviceK142198 BNX Fine Needle Aspiration SystemCovidien, LLC · 2014
- Descendant · cites it directly · 3 of its ownK150891 BNX Fine Needle Aspiration System and SharkCore LG Fine Needle…Covidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2015
- Descendant · 2 generations on · 1 of its ownK163058 Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017
- Descendant · cites it directly · 0 of its ownK180037 Beacon EUS Access SystemCovidien, LLC · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK173184 Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017
- Descendant · 2 generations on · 0 of its ownK152586 Beacon Fine Needle Fiducial SystemCovidien, LLC · 2015
Most influential descendants
Showing 5 of 5 · See all- K150891BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2015 · cites it directly3descendants
- K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017 · 2 generations on1descendant
- K180037Beacon EUS Access SystemCovidien, LLC · 2018 · cites it directly0descendants
- K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017 · 3 generations on0descendants
- K152586Beacon Fine Needle Fiducial SystemCovidien, LLC · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −6 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −5 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| −4 | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| −3 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| −2 | K103668 | BNX Fine Needle Aspiration System | Boston Endoscopic Engineering | 2010 | 5 |
| −1 | K133008 | BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25… | Beacon Endoscopic | 2013 | — |
| 0 (this device) | K142198 | BNX Fine Needle Aspiration System | Covidien, LLC | 2014 | — |
| +1 | K150891 | BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System | Covidien, LLC ( Formerly Beacon Endoscopic Corp.) | 2015 | — |
| +2 | K163058 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific | 2017 | — |
| +1 | K180037 | Beacon EUS Access System | Covidien, LLC | 2018 | 2 |
| +3 | K173184 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific | 2017 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K133008 | BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge…Summary page 4…astroenterology-Urology Devices Panel Predicate The subject device is substantially equivalent to the BNX Fine Needle Aspiration Devices: System (K133008, cleared November 20, 2013). The expanded indication for delivery of fiducial markers is substantially equi… | 2013 |
| * | K111895 | Echotip (R) Ultra Fiducial NeedleSummary page 4…anded indication for delivery of fiducial markers is substantially equivalent to the Wilson-Cook Medical EchoTip Ultra Fiducial Needle cleared under K111895 (cleared April 27, 2012). Device The BNX Fine Needle Aspiration (FNA) System is a sterile, si… | 2012 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 19 ancestors have a recall of any class.
- Of its descendants, K150891 (Covidien, LLC ( Formerly Beacon Endoscopic Corp.), 2015) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K133008.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 BNX FNA System is used to sample targeted sub-mucosal and extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle stick injury. The 19Ga. and 22Ga. BNX Aspiration Needles are also intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
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/K142198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142198: BNX Fine Needle Aspiration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142198
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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