510(k) · Cleared
ClearedBioShield biopsy valve EUS - Linear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Cleared on Nov 6, 2020 as substantially equivalent to K070420 (United States Endoscopy Group, Inc., 2007) after a 59-day review. Its family tree reaches back 1 generation to 2007. 1 later device descends from it.
- Decided
- Nov 6, 2020
- Review
- 59 days
- Class
- Class II
- Product code
- ODD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070420 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK070420 Bioshield-Ercp Biopsy Valve, Model 00711138United States Endoscopy Group, Inc. · 2007 · Recalled
- This deviceK202583 BioShield biopsy valve EUS - LinearSTERIS Corporation · 2020
- Descendant · cites it directly · 0 of its ownK233752 Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller…CenterPoint Systems, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™…CenterPoint Systems, LLC · 2024 · cites it directly0descendants
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) | K202583 | BioShield biopsy valve EUS - Linear | STERIS Corporation | 2020 | — |
| +1 | K233752 | Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™… | CenterPoint Systems, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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 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 K250573 Single Use Cannula V…score 9.7 · 2 generations · no Class I recall
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 | Decided |
|---|---|---|---|
| * | K070420 | Bioshield-Ercp Biopsy Valve, Model 00711138Summary page 5…ame: Endoscope and accessories Regulatory Class: Class II Product Code: ODD 2. Predicate Device K070420 BioShield ERCP Biopsy Valve 3. Description of Device The BioShield® biopsy valve EUS - Linear is an a… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233752 | Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™… | 2024 | 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?
How does its category compare?
All ODD devicesODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · ODD
1in 2025
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
MAUDE reports naming product code ODD, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 0 | — | 0 | 26 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 13 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The single use BioShield@ biopsy valve EUS is used to cover the opening to the biopsy/suction channel of flexible echoendoscopes. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202583: BioShield biopsy valve EUS - Linear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202583
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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