510(k) · Cleared
ClearedBeamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chongqing Jinshan Science & Technology Co., Ltd. · OCX Endoscopic Irrigation/Suction System
Cleared on Oct 20, 2021 as substantially equivalent to K113119 (Byrne Medical, Inc., 2012) and 1 other predicate after a 233-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Oct 20, 2021
- Review
- 233 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933002 (1994). 8 ancestors in all, the oldest K882048 (1988). No later device cites it as a predicate yet.
- Root · 4 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 3 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- 2 generations backK073207 Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167Celon AG Medical Instruments · 2008 · Recalled
- 1 generation backK113119 Endogator Advantage Irrigation PumpByrne Medical, Inc. · 2012
- This deviceK210618 Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump…Chongqing Jinshan Science & Technology Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −3 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| −2 | K073207 | Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167 | Celon AG Medical Instruments | 2008 | 1 |
| −1 | K113119 | Endogator Advantage Irrigation Pump | Byrne Medical, Inc. | 2012 | — |
| 0 (this device) | K210618 | Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic… | Chongqing Jinshan Science & Technology Co., Ltd. | 2021 | — |
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 |
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 |
|---|---|---|---|
| * | K113119 | Endogator Advantage Irrigation PumpSummary page 4…t Code: OoCX 5.3 Equivalence Claimed to Predicate Device The Endoscopic Imigation Pump Series is equivalent to the Endogator Advantage Irrigation Pump. Model EPA- 500 (K113119), mamufactured by BYRNE MEDICAL, INC.. Endogator Endoscopy Imgation Pump, Model Page 23 0f 747 K210618 Page 2 of… | 2012 |
| * | K060962 | Endogator Endoscopy Irrigation Pump, Model Egp-100Summary page 5…ump. Model EPA- 500 (K113119), mamufactured by BYRNE MEDICAL, INC.. Endogator Endoscopy Imgation Pump, Model Page 23 0f 747 K210618 Page 2 of 2 EGP-100 (K060962) is provided as a secondary predicate device. 5.4 Indication for Use Statement The Endoscopic Irrigation Pump Series is indicat… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K113119.
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Endoscopic Irrigation Pump Series is indicated for endoscopic irrigation for use with washing catheters, integral endoscope water jet channels and endoscope working channels.
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/K210618 · printed Nov 5, 2026
Cite this page
510(k) Report. “K210618: Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K210618
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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