510(k) Report

510(k) · Cleared

Cleared

BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)

K232951510(k) SpecialCleared Oct 20, 202329-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

Steris · ODC Endoscope Channel Accessory

Cleared on Oct 20, 2023 as substantially equivalent to K210342 (STERIS Corporation, 2021) after a 29-day review. Its family tree reaches back 3 generations to 2007.

Decided
Oct 20, 2023
Review
29 days
Class
Class II
Product code
ODC
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K070420 (2007). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestorK070420 · Bioshield-Ercp Biopsy Valve, Model 00711138 · United States Endoscopy Group, Inc. · 2007 · recalledK142068 · Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable Rrigating Adaptor, Sterile and Non-Sterile · Medovations, Inc. · 2015K210342 · BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor · STERIS Corporation · 202120052010201520202025
Other ancestors, by generation 2 generations back: 1 other ancestor K210342 · BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor · STERIS Corporation · 2021K142068 · Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable Rrigating Adaptor, Sterile and Non-Sterile · Medovations, Inc. · 2015K070420 · Bioshield-Ercp Biopsy Valve, Model 00711138 · United States Endoscopy Group, Inc. · 2007 · recalled0
  1. Root · 3 generations backK070420 Bioshield-Ercp Biopsy Valve, Model 00711138United States Endoscopy Group, Inc. · 2007 · Recalled
  2. 2 generations backK142068 Bulldog Biopsy Valve, Olympus and Fujinon;Pentax…Medovations, Inc. · 2015
  3. 1 generation backK210342 BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension…STERIS Corporation · 2021
  4. This deviceK232951 BioShield Biopsy Valve (00711124); BioShield Biopsy Valve…Steris · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K070420Bioshield-Ercp Biopsy Valve, Model 00711138United States Endoscopy Group, Inc.20071
−2K142068Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable…Medovations, Inc.2015—
−1K210342BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing…STERIS Corporation2021—
0 (this device)K232951BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125)…Steris2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201010
FIG. 1 — Lineage of K232951, 2007–2023Source: 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 ODC? 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 ODC device

  1. #1 K232329 Defendo Fujifilm 700 Single Use Biopsy Valve…score 14.0 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K210342BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield…
Summary page 6
…sy Valve Regulation Number: 21 CFR 876.1500 Product Code: ODC, OCX 2. Predicate Device BioShield – ERCP Biopsy Valve, K210342 BioShield Irrigator – Extension Tubing, K210342 BioShield Irrigating Adaptor, K210342 3. Device Description The…
STERIS Corporation2021—

Also cleared against K210342: 2 other devices →

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?

  • The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
  • 2 of the 4 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K210342.

How does its category compare?

All ODC devices

ODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · ODC

6in 2025

2008: 32009: 12010: 42011: 42012: 22015: 22016: 12017: 12018: 22019: 42020: 42021: 62022: 82023: 72024: 82025: 62026 (partial year): 1
2007high 8 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODC

106in 2025

2008: 83 days median2010: 67 days median2011: 143 days median2019: 55 days median2020: 128 days median2021: 181 days median2022: 118 days median2023: 126 days median2024: 95 days median2025: 106 days median
2007high 181 (2021) · low 55 (2019)2026

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

Recalls per year · ODC

1so far in 2026, the most since 2007

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

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

Adverse event reports per year · ODC

91in 2025

2012: 12013: 12014: 22015: 32016: 82017: 122018: 172019: 402020: 542021: 522022: 372023: 432024: 1002025: 91
2007high 100 (2024) · low 0 (2007)2025

MAUDE reports naming product code ODC, 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
20070—00
200838300
20091—00
201046700
2011414300
20122—01
20130—01
20140—02
20152—03
20161—08
20171—012
20182—017
2019455040
20204128054
20216181052
20228118037
20237126043
20248950100
20256106091
20261—1—

What is it indicated for?

The single-use BioShield biopsy valve is used to cover the opening to the biopsy/suction channel of gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain insufllation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation.

The BioShield lrrigator - extension tubing is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with the BioShield lrrigator.

The BioShield Irrigating Adaptor is intended to be used with the BioShield Biopsy Valve to provide access for irrigation.

Indications for use as stated in the FDA summary.

Also cleared against K210342

2 other devices cite the same predicate.

  • K250145Biopsy Port AdapterEndosound, Inc. · 2025
  • K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo…Medivators (A Subsidiary of Steris Corporation) · 2023

More from Steris

22 FDA decisions under this applicant name. See the company

  • K261791MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope ReprocessorSteris · 2026
  • DEN240075Prolystica Pass Thru Disinfectant WipesSteris · 2026
  • K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP…Steris · 2025
  • K242773Electro Lube NXTSteris · 2025
  • DEN230085VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) IndicatorSteris · 2024

Recent decisions in ODC

The ODC category page

  • K252933Dyne PortDyne Medical Group, Inc. · 2026
  • K250145Biopsy Port AdapterEndosound, Inc. · 2025
  • K252910Orca Air/Water and Suction ValvesBoston Scientific · 20251 recall
  • K250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems Corporation · 20252 recalls
  • K250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2025

https://510kreport.com/device/K232951 · printed Nov 6, 2026

Cite this page

510(k) Report. “K232951: BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232951

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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