510(k) · Cleared
Recalled · Class II · 2015Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139, 00711140
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 Nov 5, 2009 as substantially equivalent to K060962 (Byrne Medical, Inc., 2006) and 2 other predicates after an 86-day review. Its family tree reaches back 3 generations to 2001. It has been recalled once.
- Decided
- Nov 5, 2009
- Review
- 86 days
- Class
- Class II
- Product code
- OCX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K011016 (2001). 8 ancestors in all, the oldest K882048 (1988). No later device cites it as a predicate yet.
- Root · 3 generations backK011016 Lsi Solutions Flexible Suture Placement Device and Accessories ProductLsi Solutions · 2001 · Recalled
- 2 generations backK024301 Lsi Endoscopic External Accessory Channel and Accessories ProductLsi Solutions · 2003
- 1 generation backK033695 Irrigation Channel Tubing, Model 100135Byrne Medical, Inc. · 2003
- This deviceK092461 Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139…United States Endoscopy Group, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011016 | Lsi Solutions Flexible Suture Placement Device and Accessories Product | Lsi Solutions | 2001 | 1 |
| −2 | K024301 | Lsi Endoscopic External Accessory Channel and Accessories Product | Lsi Solutions | 2003 | — |
| −1 | K033695 | Irrigation Channel Tubing, Model 100135 | Byrne Medical, Inc. | 2003 | — |
| 0 (this device) | K092461 | Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139, 00711140 | United States Endoscopy Group, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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 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? (4)
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 |
|---|---|---|---|
| * | K060962 | Endogator Endoscopy Irrigation Pump, Model Egp-100Summary page 1…edicate Devices: a. EndoGator Endoscopy Irrigation Pump EGP 100, manufactured by Byrne Medical, Inc. (K060962). b. ERBE EIP2, (K# unknown) c. EndoGator S… | 2006 |
| * | K031773 | Endo Gator SystemSummary page 1…nc. (K060962). b. ERBE EIP2, (K# unknown) c. EndoGator System, Byrne Medical, Inc. (K031773) d. Irrigation Channel Tubing, Byrne Medical, Inc.… | 2003 |
| * | K033695 | Irrigation Channel Tubing, Model 100135Summary page 1…, Byrne Medical, Inc. (K031773) d. Irrigation Channel Tubing, Byrne Medical, Inc. .(K033695) .. ...... e. ERBE FLOTM Endoscopy Pump Tubing,… | 2003 |
| * | — | Erbe EIP2 Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 17, 2015 | Class II | Z-1943-2015 | Under Investigation by firm | The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 4 other devices also cite its predicate K060962.
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Pump and Irrigation Biopsy Valve System is intended to provide a manual, foot-controlled delivery of fluid from commercially available sterile water bottles to flexible gastrointestinal endoscopes to facilitate the irrigation and lavage of debris within the gastrointestinal tract.
The Irrigation Pump is intended as a disposable, manual, foot-controlled, irrigation pump with a bottle cap and back-flow valve that delivers fluid from sterile water bottles.
The Irrigation Biopsy Valve is intended as a disposable, replaceable valve that connects the Irrigation Pump to the accessory channel of a flexible endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092461: Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139, 00711140.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092461
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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