510(k) · Cleared

Cleared

Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412

K040018510(k) SpecialCleared Jan 20, 200414-day reviewClass II21 CFR 874.4680

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific Corp · EOQ Bronchoscope (Flexible Or Rigid)

Cleared on Jan 20, 2004 as substantially equivalent to K963252 (Boston Scientific Corp, 1996) after a 14-day review. Its family tree reaches back 2 generations to 1991. 17 later devices descend from it.

Decided: Jan 20, 2004
Review: 14 days
Class: Class II
Product code: EOQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K914181 (1991). 17 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK914181 Wang/Mill-Rose Transbronchial Aspiration NeedleMill-Rose Laboratory · 1991 · Recalled
1 generation backK963252 TBANBoston Scientific Corp · 1996
This deviceK040018 Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412Boston Scientific Corp · 2004
Descendant · cites it directly · 15 of its ownK142839 GenCut Core Biopsy SystemCovidien, LLC · 2015
Descendant · 2 generations on · 14 of its ownK163537 Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC · 2017
Descendant · 3 generations on · 12 of its ownK182188 Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical · 2019 · Recalled
Descendant · 4 generations on · 5 of its ownK202370 Ion Endoluminal SystemIntuitive Surgical, Inc. · 2020
Descendant · 5 generations on · 4 of its ownK220299 Ion Endoluminal System (IF1000)Intuitive Surgical, Inc. · 2022

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2009high 3 (2025) · low 0 (2010)2026

Most influential descendants

Showing 5 of 17 · See all

K142839GenCut Core Biopsy SystemCovidien, LLC · 2015 · cites it directly15descendants
K163537Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC · 2017 · 2 generations on14descendants
K182188Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical · 2019 · 3 generations on12descendants
K202370Ion Endoluminal SystemIntuitive Surgical, Inc. · 2020 · 4 generations on5descendants
K220299Ion Endoluminal System (IF1000)Intuitive Surgical, Inc. · 2022 · 5 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K914181	Wang/Mill-Rose Transbronchial Aspiration Needle	Mill-Rose Laboratory	1991	4
−1	K963252	TBAN	Boston Scientific Corp	1996	—
0 (this device)	K040018	Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412	Boston Scientific Corp	2004	—
+1	K142839	GenCut Core Biopsy System	Covidien, LLC	2015	—
+2	K163537	Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga	Covidien, LLC	2017	—
+3	K182188	Ion Endoluminal System ; Flexision Biopsy Needle	Intuitive Surgical	2019	5
+4	K202370	Ion Endoluminal System	Intuitive Surgical, Inc.	2020	—
+5	K220299	Ion Endoluminal System (IF1000)	Intuitive Surgical, Inc.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2015	1	0
2017	1	0
2019	2	0
2020	2	0
2021	1	0
2022	2	0
2023	2	0
2024	2	0
2025	3	0

FIG. 1 — Lineage of K040018, 1991–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 EOQ? 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 EOQ device

#1 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K963252	TBAN Summary page 1 …Class 1L, per 21 CFR Part 874.4680 PREDICATE DEVICE: Boston Scientific StifcorTm Transbronchial Aspiration Needle (K963252) DESCRIPTION: The eXcelOnjTm Transbronchial Aspiration Needle is a needle…	Boston Scientific Corp	1996	—

Also cleared against K963252: 2 other devices →

What descends from it? (17)

See all 17

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K142839	GenCut Core Biopsy System	Covidien, LLC	2015	15
K090853	Yield Tissue Sampler	Broncus Technologies, Inc.	2009	0

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 13 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
1 of the 2 ancestors has a recall of any class.
Of its descendants, K142839 (Covidien, LLC, 2015) has gone furthest, with 15 descendants of its own.
2 other devices also cite its predicate K963252.

How does its category compare?

All EOQ devices

EOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EOQ

20in 2025

2007high 20 (2025) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EOQ

147in 2025

2007high 302 (2014) · low 24 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EOQ

25in 2025

2007high 25 (2025) · low 0 (2007)2026

Class I (28 since 2007) Class II/III not classified

Adverse event reports per year · EOQ

6,546in 2025

2007high 6,546 (2025) · low 39 (2007)2025

MAUDE reports naming product code EOQ, 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	2	—	0	39
2008	2	—	0	87
2009	3	24	0	114
2010	0	—	0	100
2011	0	—	1	96
2012	2	—	4	93
2013	4	178	0	93
2014	3	302	0	98
2015	6	206	0	132
2016	3	262	1	297
2017	4	136	0	337
2018	7	212	0	279
2019	11	147	1	654
2020	10	103	1	515
2021	15	169	9	1,358
2022	11	134	5	2,541
2023	12	160	18 (4)	5,064
2024	13	130	4	6,051
2025	20	147	25 (24)	6,546
2026	9	206	0	—

What is it indicated for?

Indicated for use in aspiration in carinal, paratracheal and hilar lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040018 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040018: Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040018

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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