510(k) · Cleared
Recalled · Class II · 2017BNX Fine Needle Aspiration System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Endoscopic Engineering · FCG Biopsy Needle
Cleared on Dec 30, 2010 as substantially equivalent to K083330 (Cook Endoscopy, 2009) and 1 other predicate after a 14-day review. Its family tree reaches back 5 generations to 1995. 8 later devices descend from it. It has been recalled 5 times.
- Decided
- Dec 30, 2010
- Review
- 14 days
- Class
- Class II
- Product code
- FCG
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 5 generations to K935844 (1995). 12 ancestors in all, the oldest K904667 (1990). 8 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 4 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 3 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- 2 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- 1 generation backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- This deviceK103668 BNX Fine Needle Aspiration SystemBoston Endoscopic Engineering · 2010
- Descendant · cites it directly · 7 of its ownK133008 BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19…Beacon Endoscopic · 2013
- Descendant · 2 generations on · 5 of its ownK142198 BNX Fine Needle Aspiration SystemCovidien, LLC · 2014
- Descendant · 2 generations on · 4 of its ownK141894 Sharkcore Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2014
- Descendant · 3 generations on · 3 of its ownK150891 BNX Fine Needle Aspiration System and SharkCore LG Fine Needle…Covidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2015
- Descendant · 4 generations on · 1 of its ownK163058 Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K133008BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge…Beacon Endoscopic · 2013 · cites it directly7descendants
- K142198BNX Fine Needle Aspiration SystemCovidien, LLC · 2014 · 2 generations on5descendants
- K141894Sharkcore Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2014 · 2 generations on4descendants
- K150891BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2015 · 3 generations on3descendants
- K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −4 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −3 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| −2 | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| −1 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| 0 (this device) | K103668 | BNX Fine Needle Aspiration System | Boston Endoscopic Engineering | 2010 | — |
| +1 | K133008 | BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25… | Beacon Endoscopic | 2013 | — |
| +2 | K142198 | BNX Fine Needle Aspiration System | Covidien, LLC | 2014 | — |
| +2 | K141894 | Sharkcore Fine Needle Biopsy System | Covidien, LLC ( Formerly Beacon Endoscopic Corp.) | 2014 | — |
| +3 | K150891 | BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System | Covidien, LLC ( Formerly Beacon Endoscopic Corp.) | 2015 | — |
| +4 | K163058 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific | 2017 | — |
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 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 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 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 |
|---|---|---|---|
| * | K083330 | Echotip Ultra Ultrasound NeedleSummary page 1…logy-Urology Devices Panel Predicate Devices: The subject device issubstantially equivalent to the: * Cook Medical Echorip Ultrasound Needle (K083330, cleared 2/6/2009) and * Olympus Single-Use Aspiration Needle (K023272, clear… | 2009 |
| * | K023272 | Disposable Aspiration Needle NA-200HSummary page 1…* Cook Medical Echorip Ultrasound Needle (K083330, cleared 2/6/2009) and * Olympus Single-Use Aspiration Needle (K023272, cleared 12/23/2002). Device The BNX Fine Needle Aspiration System is a sterile, sing… | 2002 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133008 | BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge… | 2013 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 8, 2017 | Class II | Z-1475-2017 | Nonconforming Material/Component | Handle may break during use. |
| Feb 8, 2017 | Class II | Z-1473-2017 | Nonconforming Material/Component | Handle may break during use. |
| Feb 8, 2017 | Class II | Z-1476-2017 | Nonconforming Material/Component | Handle may break during use. |
| Feb 8, 2017 | Class II | Z-1474-2017 | Nonconforming Material/Component | Handle may break during use. |
| Feb 8, 2017 | Class II | Z-1472-2017 | Nonconforming Material/Component | Handle may break during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K133008 (Beacon Endoscopic, 2013) has gone furthest, with 7 descendants of its own.
- 8 other devices also cite its predicate K083330.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 BNX Fine Needle Aspiration System is used to sample targeted sub-mucosal and extramural lesions of the gastrointestinal tract through the accessory channel of an ultrasound endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103668 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103668: 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/K103668
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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