510(k) · Cleared

Recalled · Class I · 2025

Olympus Guide Sheath, Model XBO1-836-13

K060243510(k) TraditionalCleared Jun 23, 2006143-day reviewClass II21 CFR 874.4680Recalls 9 (1 Class I)

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

Olympus Medical Systems Corporation · EOQ Bronchoscope (Flexible Or Rigid)

Cleared on Jun 23, 2006 as substantially equivalent to K931154 (Olympus Corp., 1993) after a 143-day review. Its family tree reaches back 1 generation to 1993. 1 of the 13 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it. It has been recalled 9 times, including a Class I recall.

Decided: Jun 23, 2006
Review: 143 days
Class: Class II
Product code: EOQ
Recalls: 9 (1 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to K931154 (1993). 11 later devices descend from it, 4 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK931154 Evis 200 SystemOlympus Corp. · 1993
This deviceK060243 Olympus Guide Sheath, Model XBO1-836-13Olympus Medical Systems Corporation · 2006
Descendant · cites it directly · 5 of its ownK131234 Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon)Broncus Medical, Inc. · 2013
Descendant · 2 generations on · 2 of its ownK142934 CrossCountry Transbronchial Access Tool straight, CrossCountry…Covidien · 2015
Descendant · cites it directly · 1 of its ownK192164 Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding…Olympus Medical Systems Corp. · 2020
Descendant · cites it directly · 1 of its ownK172955 LungVision ToolBodyvision Medical, Ltd. · 2018
Descendant · cites it directly · 0 of its ownK254037 LungFlow Airway CatheterFree Flow Medical, Inc. · 2026

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2013high 2 (2015) · low 0 (2014)2026

Most influential descendants

Showing 5 of 11 · See all

K131234Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon)Broncus Medical, Inc. · 2013 · cites it directly5descendants
K142934CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access…Covidien · 2015 · 2 generations on2descendants
K192164Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DROlympus Medical Systems Corp. · 2020 · cites it directly1descendant
K172955LungVision ToolBodyvision Medical, Ltd. · 2018 · cites it directly1descendant
K254037LungFlow Airway CatheterFree Flow Medical, Inc. · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K931154	Evis 200 System	Olympus Corp.	1993	—
0 (this device)	K060243	Olympus Guide Sheath, Model XBO1-836-13	Olympus Medical Systems Corporation	2006	—
+1	K131234	Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon)	Broncus Medical, Inc.	2013	—
+2	K142934	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial…	Covidien	2015	—
+1	K192164	Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR	Olympus Medical Systems Corp.	2020	—
+1	K172955	LungVision Tool	Bodyvision Medical, Ltd.	2018	—
+1	K254037	LungFlow Airway Catheter	Free Flow Medical, Inc.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	2	0
2018	1	0
2020	1	0
2021	2	0
2022	1	0
2024	1	0
2026	2	0

FIG. 1 — Lineage of K060243, 1993–2026Source: 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.

1 device in this family has a Class I recall. 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
*	K931154	Evis 200 System Summary page 1 …ass II , EOQ C. PREDICATE DEVICES Device Name 51 0(k) # Manufacturer Class Crodec Cytology Brush: BC-14/15/16C #K931154 Olympus BI EGO (EVIS 2008Sstem) Corporation.…	Olympus Corp.	1993	—

Also cleared against K931154: 9 other devices →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K131234	Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon)	Broncus Medical, Inc.	2013	5
K192164	Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR	Olympus Medical Systems Corp.	2020	1
K172955	LungVision Tool	Bodyvision Medical, Ltd.	2018	1
K254037	LungFlow Airway Catheter	Free Flow Medical, Inc.	2026	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 15, 2025	Class I	Z-1071-2025	Under Investigation by firm	Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Jan 4, 2021	Class II	Z-0973-2021	Under Investigation by firm	Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Jan 4, 2021	Class II	Z-0970-2021	Under Investigation by firm	Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Jan 4, 2021	Class II	Z-0971-2021	Under Investigation by firm	Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Jan 4, 2021	Class II	Z-0972-2021	Under Investigation by firm	Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Jan 4, 2021	Class II	Z-1050-2021	Under Investigation by firm	Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Jan 4, 2021	Class II	Z-1052-2021	Under Investigation by firm	Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Jan 4, 2021	Class II	Z-1051-2021	Under Investigation by firm	Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Jan 4, 2021	Class II	Z-1053-2021	Under Investigation by firm	Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

The 5 latest of 9 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K131234 (Broncus Medical, Inc., 2013) has gone furthest, with 5 descendants of its own.
9 other devices also cite its predicate K931154.

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?

This instrument has been designed to be used with Olympus bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area within the respiratory organs.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060243 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060243: Olympus Guide Sheath, Model XBO1-836-13.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060243

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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