510(k) · Cleared

Recalled · Class II · 2012

Wang/Mill-Rose Transbronchial Aspiration Needle

K914181510(k) TraditionalCleared Dec 10, 199183-day reviewClass II21 CFR 874.4680Recalls 4

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

Mill-Rose Laboratory · EOQ Bronchoscope (Flexible Or Rigid)

Cleared on Dec 10, 1991 after an 83-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 38 later devices descend from it. It has been recalled 4 times.

Decided: Dec 10, 1991
Review: 83 days
Class: Class II
Product code: EOQ
Recalls: 4
Predicates: 0

38 later devices descend from it, 9 citing it directly.

This deviceK914181 Wang/Mill-Rose Transbronchial Aspiration NeedleMill-Rose Laboratory · 1991
Descendant · cites it directly · 19 of its ownK963252 TBANBoston Scientific Corp · 1996
Descendant · 2 generations on · 17 of its ownK040018 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 · cites it directly · 14 of its ownK163537 Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC · 2017
Descendant · 2 generations on · 12 of its ownK182188 Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical · 2019 · Recalled

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

1996high 4 (2023) · low 0 (1997)2026

Most influential descendants

Showing 5 of 38 · See all

K963252TBANBoston Scientific Corp · 1996 · cites it directly19descendants
K040018Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412Boston Scientific Corp · 2004 · 2 generations on17descendants
K142839GenCut Core Biopsy SystemCovidien, LLC · 2015 · cites it directly15descendants
K163537Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC · 2017 · cites it directly14descendants
K182188Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical · 2019 · 2 generations on12descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1998	3	0
2003	1	0
2004	1	0
2009	1	0
2015	2	0
2017	3	0
2018	2	0
2019	2	0
2020	3	0
2021	3	0
2022	2	0
2023	4	0
2024	3	0
2025	4	0
2026	2	0

FIG. 1 — Lineage of K914181, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (38)

See all 38

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

Number	Device	Applicant	Decided	Descendants
K963252	TBAN	Boston Scientific Corp	1996	19
K142839	GenCut Core Biopsy System	Covidien, LLC	2015	15
K163537	Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga	Covidien, LLC	2017	14
K162611	PeriFLEX	Spiration, Inc.	2017	12
K142934	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access…	Covidien	2015	2
K984157	Modification to Wilson-Cook Lung Biopsy Needle	Wilson-Cook Medical, Inc.	1998	0
K983122	Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Combination…	Mill-Rose Laboratory	1998	0
K983124	Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Cytology Procedural Kit	Mill-Rose Laboratory	1998	0
K962736	Mill-Rose Laryngoscopic Injection Needle	Mill-Rose Laboratory	1996	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 20, 2012	Class II	Z-0502-2013	Component design/selection	ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument…
Nov 20, 2012	Class II	Z-0503-2013	Component design/selection	ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument…
Nov 20, 2012	Class II	Z-0504-2013	Component design/selection	ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument…
Nov 20, 2012	Class II	Z-0505-2013	Component design/selection	ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K963252 (Boston Scientific Corp, 1996) has gone furthest, with 19 descendants of its own.

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	—

https://510kreport.com/device/K914181 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914181: Wang/Mill-Rose Transbronchial Aspiration Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914181

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026