510(k) · Cleared
ClearedEndoscopic Water Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou AGS MedTech Co., Ltd. · OCX Endoscopic Irrigation/Suction System
Cleared on Mar 20, 2025 as substantially equivalent to K100899 (Keymed (Medical & Industrial Equipment), Ltd., 2010) after a 280-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Mar 20, 2025
- Review
- 280 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K933002 (1994). 8 ancestors in all, the oldest K926514 (1993). 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 backK100899 Olympus Endoscopic Flushing Pump, Model Opf-2Keymed (Medical & Industrial Equipment), Ltd. · 2010 · Recalled
- This deviceK241704 Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd. · 2025
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 | K100899 | Olympus Endoscopic Flushing Pump, Model Opf-2 | Keymed (Medical & Industrial Equipment), Ltd. | 2010 | 3 |
| 0 (this device) | K241704 | Endoscopic Water Pump | Hangzhou AGS MedTech Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 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? (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 |
|---|---|---|---|
| * | K100899 | Olympus Endoscopic Flushing Pump, Model Opf-2Summary page 6…/ Device Name: Olympus Endoscopic Flushing Pump(OFP-2) Common Name: Endoscopic Flushing or Lavage Pump 510(K) Number: K100899 Regulation class: Class II Regulation Number: 876.1500 Regulation Description: Endoscope and accessories Review… | 2010 |
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 31 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- 4 of the 8 ancestors have a recall of any class.
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Water Pump is a peristaltic pump intended to supply fluid to compatible
endoscopes or endotherapy devices for irrigation of the gastric and colonic mucosa during
endoscopic or endotherapeutic procedures, allowing to aid in visualisation, diagnosis and treatment.
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/K241704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241704: Endoscopic Water Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241704
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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