510(k) · Cleared
Recalled · Class II · 2013Irrigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Endoscopy Group, Inc. · OCX Endoscopic Irrigation/Suction System
Cleared on Dec 30, 2010 after a 58-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it. It has been recalled once.
- Decided
- Dec 30, 2010
- Review
- 58 days
- Class
- Class II
- Product code
- OCX
- Recalls
- 1
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK103239 Irrigation SystemUnited States Endoscopy Group, Inc. · 2010
- 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
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 |
|---|---|---|---|---|---|
| 0 (this device) | K103239 | Irrigation System | United States Endoscopy Group, Inc. | 2010 | — |
| +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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 7, 2013 | Class II | Z-1099-2013 | Device Design | The firm was notified by their customers that there was a water leakage from the white tubing connector. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K210342 (STERIS Corporation, 2021) has gone furthest, with 6 descendants of its own.
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OCX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCX
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCX
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCX
33in 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 Irrigation System (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K103239 · printed Nov 3, 2026
Cite this page
510(k) Report. “K103239: Irrigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K103239
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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