510(k) · Cleared
ClearedBioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · ODC Endoscope Channel Accessory
Cleared on Sep 3, 2021 as substantially equivalent to K070420 (United States Endoscopy Group, Inc., 2007) and 2 other predicates after a 210-day review. Its family tree reaches back 2 generations to 2007. 6 later devices descend from it.
- Decided
- Sep 3, 2021
- Review
- 210 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K070420 (2007). 3 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK070420 Bioshield-Ercp Biopsy Valve, Model 00711138United States Endoscopy Group, Inc. · 2007 · Recalled
- 1 generation backK142068 Bulldog Biopsy Valve, Olympus and Fujinon;Pentax…Medovations, Inc. · 2015
- This deviceK210342 BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension…STERIS Corporation · 2021
- Descendant · cites it directly · 3 of its ownK232329 Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700…Medivators (A Subsidiary of Steris Corporation) · 2023
- Descendant · 2 generations on · 1 of its ownK240352 Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation · 2024
- Descendant · cites it directly · 0 of its ownK250145 Biopsy Port AdapterEndosound, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK250140 Defendo Fujifilm 700 Single Use Cleaning AdapterSteris Corparation · 2025
- Descendant · 3 generations on · 0 of its ownK243075 Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322…STERIS Corporation · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water…Medivators (A Subsidiary of Steris Corporation) · 2023 · cites it directly3descendants
- K240352Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation · 2024 · 2 generations on1descendant
- K250145Biopsy Port AdapterEndosound, Inc. · 2025 · cites it directly0descendants
- K250140Defendo Fujifilm 700 Single Use Cleaning AdapterSteris Corparation · 2025 · 2 generations on0descendants
- K243075Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096…STERIS Corporation · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070420 | Bioshield-Ercp Biopsy Valve, Model 00711138 | United States Endoscopy Group, Inc. | 2007 | 1 |
| −1 | K142068 | Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable… | Medovations, Inc. | 2015 | — |
| 0 (this device) | K210342 | BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing… | STERIS Corporation | 2021 | — |
| +1 | K232329 | Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use… | Medivators (A Subsidiary of Steris Corporation) | 2023 | — |
| +2 | K240352 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes | STERIS Corporation | 2024 | — |
| +1 | K250145 | Biopsy Port Adapter | Endosound, Inc. | 2025 | — |
| +2 | K250140 | Defendo Fujifilm 700 Single Use Cleaning Adapter | Steris Corparation | 2025 | — |
| +3 | K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323… | STERIS Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
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 K232329 Defendo Fujifilm 700 Single Use Biopsy Valve…score 14.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K070420 | Bioshield-Ercp Biopsy Valve, Model 00711138Summary page 5…sy Valve Regulation Number: 21 CFR 876.1500 Product Code: OCX, ODC 2. Predicate Device BioShield – ERCP Biopsy Valve, K070420 Irrigation System, K103239 Medovations BullDog Biopsy Valve Irrigating Adaptor Accessory, K142068 3. Device Descript… | 2007 |
| * | K103239 | Irrigation SystemSummary page 5…21 CFR 876.1500 Product Code: OCX, ODC 2. Predicate Device BioShield – ERCP Biopsy Valve, K070420 Irrigation System, K103239 Medovations BullDog Biopsy Valve Irrigating Adaptor Accessory, K142068 3. Device Description The BioShield biopsy va… | 2010 |
| * | K142068 | Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable Rrigating…Summary page 5…C 2. Predicate Device BioShield – ERCP Biopsy Valve, K070420 Irrigation System, K103239 Medovations BullDog Biopsy Valve Irrigating Adaptor Accessory, K142068 3. Device Description The BioShield biopsy valve is a single-use disposable cap that is used to cover the biopsy/suc… | 2015 |
| † | K210981 | Pure Vu System | 2021 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K232329 (Medivators (A Subsidiary of Steris Corporation), 2023) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K070420.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · ODC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODC
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODC
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODC
91in 2025
MAUDE reports naming product code ODC, 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 | 3 | 83 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 67 | 0 | 0 |
| 2011 | 4 | 143 | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 8 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 4 | 55 | 0 | 40 |
| 2020 | 4 | 128 | 0 | 54 |
| 2021 | 6 | 181 | 0 | 52 |
| 2022 | 8 | 118 | 0 | 37 |
| 2023 | 7 | 126 | 0 | 43 |
| 2024 | 8 | 95 | 0 | 100 |
| 2025 | 6 | 106 | 0 | 91 |
| 2026 | 1 | — | 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 insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation.
The BioShield Irrigator — 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 Irrigator.
The BioShield Irrigating Adaptor is intended to be used with the BioShield Biopsy Valve to provide 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.
https://510kreport.com/device/K210342 · printed Nov 3, 2026
Cite this page
510(k) Report. “K210342: BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K210342
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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