510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Bioshield-Ercp Biopsy Valve, Model 00711138

K070420510(k) TraditionalCleared Mar 19, 200727-day reviewClass II21 CFR 876.1500Recalls 1

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

United States Endoscopy Group, Inc. · ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula

Cleared on Mar 19, 2007 after a 27-day review. The FDA summary names no predicate by number. 12 later devices descend from it. It has been recalled once.

Decided
Mar 19, 2007
Review
27 days
Class
Class II
Product code
ODD
Recalls
1
Predicates
0

12 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2021: 1 descendant cleared2020: 1 descendant cleared2010: 1 descendant cleared2018: 1 descendant cleared2024: 3 descendants cleared2023: 2 descendants cleared2025: 2 descendants cleared20052010201520202025
  1. This deviceK070420 Bioshield-Ercp Biopsy Valve, Model 00711138United States Endoscopy Group, Inc. · 2007
  2. Descendant · cites it directly · 8 of its ownK142068 Bulldog Biopsy Valve, Olympus and Fujinon;Pentax…Medovations, Inc. · 2015
  3. Descendant · cites it directly · 6 of its ownK210342 BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension…STERIS Corporation · 2021
  4. 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
  5. Descendant · 3 generations on · 1 of its ownK240352 Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation · 2024
  6. Descendant · cites it directly · 1 of its ownK202583 BioShield biopsy valve EUS - LinearSTERIS Corporation · 2020

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2010: 12015: 12018: 12020: 12021: 12023: 22024: 32025: 2
2010high 3 (2024) · low 0 (2011)2026

Most influential descendants

Showing 5 of 12 · See all
  • K142068Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable Rrigating…Medovations, Inc. · 2015 · cites it directly8descendants
  • 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
  • K202583BioShield biopsy valve EUS - LinearSTERIS Corporation · 2020 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K070420Bioshield-Ercp Biopsy Valve, Model 00711138United States Endoscopy Group, Inc.2007—
+1K142068Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable…Medovations, Inc.2015—
+1K210342BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing…STERIS Corporation2021—
+2K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use…Medivators (A Subsidiary of Steris Corporation)2023—
+3K240352Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation2024—
+1K202583BioShield biopsy valve EUS - LinearSTERIS Corporation2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201510
201810
202010
202110
202320
202430
202520
FIG. 1 — Lineage of K070420, 2007–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 ODD? 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 ODD device

  1. #1 K250573 Single Use Cannula V…score 9.7 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K142068Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable Rrigating…Medovations, Inc.20158
K210342BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield…STERIS Corporation20216
K202583BioShield biopsy valve EUS - LinearSTERIS Corporation20201
K101094ClearjetEasyglide, Ltd.20100

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 31, 2014Class IIZ-0861-2015Equipment maintenancePackaging non-conformance related to the integrity of the sterile pouch seal.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K142068 (Medovations, Inc., 2015) has gone furthest, with 8 descendants of its own.

How does its category compare?

All ODD devices

ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · ODD

1in 2025

2007: 12018: 12020: 12025: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODD

Too few ODD 510(k)s in any year since 2007 to give a median.

Recalls per year · ODD

No recall names ODD since 2007.

Adverse event reports per year · ODD

4in 2025

2007: 12008: 92009: 262012: 22015: 12016: 22017: 22018: 132019: 52020: 112021: 82022: 112023: 152024: 122025: 4
2007high 26 (2009) · low 0 (2010)2025

MAUDE reports naming product code ODD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—01
20080—09
20090—026
20100—00
20110—00
20120—02
20130—00
20140—00
20150—01
20160—02
20170—02
20181—013
20190—05
20201—011
20210—08
20220—011
20230—015
20240—012
20251—04
20260—0—

What is it indicated for?

The single use BioShield® - ERCP biopsy valve is used to cover the opening to the biopsy/suction channel of Olympus and G5 and newer Fujinon 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from United States Endoscopy Group, Inc.

94 FDA decisions under this applicant name. See the company

  • K192265gi-4000 Electrosurgical GeneratorUnited States Endoscopy Group, Inc. · 20201 recall
  • K200745Lariat, Hot/Cold SnareUnited States Endoscopy Group, Inc. · 2020
  • K192059Bio Guard Air/Water & Suction ValvesUnited States Endoscopy Group, Inc. · 2019
  • K191559AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILMUnited States Endoscopy Group, Inc. · 2019
  • K182909Roth Net Retriever Product LineUnited States Endoscopy Group, Inc. · 2018

Recent decisions in ODD

The ODD category page

  • K250573Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614MOlympus Medical Systems Corp. · 2025
  • K202583BioShield biopsy valve EUS - LinearSTERIS Corporation · 2020
  • K171989Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter…Wilson-Cook Medical, Inc. · 2018
  • K011149Disposable Bending Cannula PR-233QThe Olympus Optical Co. · 2001
  • K010993Alien RX Micro Cannula, Model 4530Boston Scientific Corp · 2001

https://510kreport.com/device/K070420 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070420: Bioshield-Ercp Biopsy Valve, Model 00711138.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070420

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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