510(k) · Cleared

Cleared

Captura Disposable Bronchoscope Biopsy Forceps

K163377510(k) TraditionalCleared Feb 21, 2018447-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

Wilson-Cook Medical, Inc. · EOQ Bronchoscope (Flexible Or Rigid)

Cleared on Feb 21, 2018 as substantially equivalent to K923847 (Wilson-Cook Medical, Inc., 1992) after a 447-day review. Its family tree reaches back 1 generation to 1992.

Decided: Feb 21, 2018
Review: 447 days
Class: Class II
Product code: EOQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K923847 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK923847 Disposable Bronchoscope Biopsy ForcepsWilson-Cook Medical, Inc. · 1992
This deviceK163377 Captura Disposable Bronchoscope Biopsy ForcepsWilson-Cook Medical, Inc. · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923847	Disposable Bronchoscope Biopsy Forceps	Wilson-Cook Medical, Inc.	1992	—
0 (this device)	K163377	Captura Disposable Bronchoscope Biopsy Forceps	Wilson-Cook Medical, Inc.	2018	—

FIG. 1 — Lineage of K163377, 1992–2018Source: 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
*	K923847	Disposable Bronchoscope Biopsy Forceps Summary page 4 …flexible or rigid) and accessories 21 CFR §874.4680, EOQ, Class II Predicate Device: Disposable Bronchoscope Biopsy Forceps, K923847, cleared November 18, 1992 Indications for Use This device is used in obtaining biopsy samples in the bronchi or lungs. This dev…	Wilson-Cook Medical, Inc.	1992	—

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.

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. 2018, this device’s year, is highlighted.

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?

This device is used in obtaining biopsy samples in the bronchi or lungs. This device is indicated for adult use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K163377 · printed Nov 4, 2026

Cite this page

510(k) Report. “K163377: Captura Disposable Bronchoscope Biopsy Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163377

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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