510(k) · Cleared

Cleared

Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable Rrigating Adaptor, Sterile and Non-Sterile

K142068510(k) TraditionalCleared Mar 10, 2015223-day reviewClass II21 CFR 876.1500

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

Medovations, Inc. · OCX Endoscopic Irrigation/Suction System

Cleared on Mar 10, 2015 as substantially equivalent to K070420 (United States Endoscopy Group, Inc., 2007) after a 223-day review. Its family tree reaches back 1 generation to 2007. 8 later devices descend from it.

Decided: Mar 10, 2015
Review: 223 days
Class: Class II
Product code: OCX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K070420 (2007). 8 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK070420 Bioshield-Ercp Biopsy Valve, Model 00711138United States Endoscopy Group, Inc. · 2007 · Recalled
This deviceK142068 Bulldog Biopsy Valve, Olympus and Fujinon;Pentax…Medovations, Inc. · 2015
Descendant · cites it directly · 6 of its ownK210342 BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension…STERIS Corporation · 2021
Descendant · 2 generations on · 3 of its ownK232329 Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700…Medivators (A Subsidiary of Steris Corporation) · 2023
Descendant · 3 generations on · 1 of its ownK240352 Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation · 2024
Descendant · 2 generations on · 0 of its ownK250145 Biopsy Port AdapterEndosound, Inc. · 2025
Descendant · 3 generations on · 0 of its ownK250140 Defendo Fujifilm 700 Single Use Cleaning AdapterSteris Corparation · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2018high 2 (2023) · low 0 (2019)2026

Most influential descendants

Showing 5 of 8 · See all

K210342BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield…STERIS Corporation · 2021 · cites it directly6descendants
K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water…Medivators (A Subsidiary of Steris Corporation) · 2023 · 2 generations on3descendants
K240352Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation · 2024 · 3 generations on1descendant
K250145Biopsy Port AdapterEndosound, Inc. · 2025 · 2 generations on0descendants
K250140Defendo Fujifilm 700 Single Use Cleaning AdapterSteris Corparation · 2025 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K070420	Bioshield-Ercp Biopsy Valve, Model 00711138	United States Endoscopy Group, Inc.	2007	1
0 (this device)	K142068	Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable…	Medovations, Inc.	2015	—
+1	K210342	BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing…	STERIS Corporation	2021	—
+2	K232329	Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use…	Medivators (A Subsidiary of Steris Corporation)	2023	—
+3	K240352	Defendo Single Use Cleaning Adapter for Olympus Endoscopes	STERIS Corporation	2024	—
+2	K250145	Biopsy Port Adapter	Endosound, Inc.	2025	—
+3	K250140	Defendo Fujifilm 700 Single Use Cleaning Adapter	Steris Corparation	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0
2021	1	0
2023	2	0
2024	2	0
2025	2	0

FIG. 1 — Lineage of K142068, 2007–2025Source: 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 OCX? 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 OCX device

#1 K251986 Auxiliary Water Tube Maj-855score 12.8 · 10 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
*	K070420	Bioshield-Ercp Biopsy Valve, Model 00711138 Summary page 4 …X - Endoscopic Irrigation/Suction System Regulation Number: 21 CFR 876.1500 4. Predicate Device Identification Predicate Device 510(k) No.: K070420 Predicate Device Trade Name: US Endoscopy BioShield® ERCP Biopsy Valve Predicate Device Product Code: KOG 5. Ge…	United States Endoscopy Group, Inc.	2007	1

Also cleared against K070420: 3 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K210342	BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield…	STERIS Corporation	2021	6
K173758	Disposable Biopsy Valve	Zhejiang Chuangxiang Medical Technology Co., Ltd.	2018	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?

Its one ancestor has a recall.
Of its descendants, K210342 (STERIS Corporation, 2021) has gone furthest, with 6 descendants of its own.
3 other devices also cite its predicate K070420.

How does its category compare?

All OCX devices

OCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · OCX

4in 2025

2007high 8 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCX

178in 2025

2007high 256 (2012) · low 51 (2010)2026

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

Recalls per year · OCX

2in 2022

2007high 11 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OCX

33in 2025

2007high 46 (2023) · low 0 (2007)2025

MAUDE reports naming product code OCX, 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	0	—	0	0
2008	0	—	0	1
2009	1	—	0	0
2010	3	51	0	0
2011	1	—	0	0
2012	4	256	0	1
2013	3	106	0	1
2014	6	77	0	5
2015	2	—	1	9
2016	2	—	0	8
2017	0	—	0	9
2018	5	60	0	18
2019	8	133	0	41
2020	4	88	11	11
2021	3	233	0	8
2022	6	84	2	18
2023	7	109	0	46
2024	4	74	0	21
2025	4	178	0	33
2026	0	—	2	—

What is it indicated for?

The single use Medovations BullDog® biopsy valve is used to cover the opening to the biopsy/suction channel of Olympus® and Fujinon® or Pentax® gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K142068 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142068: Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable Rrigating Adaptor, Sterile and Non-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142068

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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