510(k) · Cleared
ClearedEndogator Advantage Irrigation Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Byrne Medical, Inc. · OCX Endoscopic Irrigation/Suction System
Cleared on Apr 27, 2012 as substantially equivalent to K060962 (Byrne Medical, Inc., 2006) and 1 other predicate after a 189-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Apr 27, 2012
- Review
- 189 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K933002 (1994). 7 ancestors in all, the oldest K882048 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 2 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- 1 generation backK073207 Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167Celon AG Medical Instruments · 2008 · Recalled
- This deviceK113119 Endogator Advantage Irrigation PumpByrne Medical, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK210618 Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump…Chongqing Jinshan Science & Technology Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK152278 ENDOFLOW II - Irrigation, Warming and Suction SystemPromepla Sam · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −2 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| −1 | K073207 | Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167 | Celon AG Medical Instruments | 2008 | 1 |
| 0 (this device) | K113119 | Endogator Advantage Irrigation Pump | Byrne Medical, Inc. | 2012 | — |
| +1 | K210618 | Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic… | Chongqing Jinshan Science & Technology Co., Ltd. | 2021 | — |
| +1 | K152278 | ENDOFLOW II - Irrigation, Warming and Suction System | Promepla Sam | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 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? (2)
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…y Device Class: 11 Regulation No.: 876.1500 Date Prepared: April 23, 2012 Predicate Devices: Byrne Medical EndloGator Pump Model EGP-100 K060962 Olympus AFU-100 Irrigation Pump K073207 Medivators has provided the following information to the U.S. Foo… | 2006 |
| * | K073207 | Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167Summary page 1…ate Prepared: April 23, 2012 Predicate Devices: Byrne Medical EndloGator Pump Model EGP-100 K060962 Olympus AFU-100 Irrigation Pump K073207 Medivators has provided the following information to the U.S. Food and Drug Administration to support the substantial equivalence… | 2008 |
What descends from it? (2)
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)
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 18 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K210618 (Chongqing Jinshan Science & Technology Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 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. 2012, 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 EndoGator Advantage Irrigation Pump is indicated for endoscopic irrigation for use with washing catheters, integral endoscope water jet channels and endoscope working channels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113119: Endogator Advantage Irrigation Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113119
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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