510(k) · Cleared
ClearedAquaPulse Irrigation Tubing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ga Health Company Limited · OCX Endoscopic Irrigation/Suction System
Cleared on Dec 10, 2020 as substantially equivalent to K092429 (Byrne Medical, Inc., 2009) after a 97-day review. Its family tree reaches back 3 generations to 1988. 2 later devices descend from it.
- Decided
- Dec 10, 2020
- Review
- 97 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K884836 (1988). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK884836 Universal Generator Irrigator Model Ugi-3000Meditron Devices, Inc. · 1988
- 2 generations backK031773 Endo Gator SystemByrne Medical, Inc. · 2003
- 1 generation backK092429 EndogatorByrne Medical, Inc. · 2009
- This deviceK202560 AquaPulse Irrigation TubingGa Health Company Limited · 2020
- Descendant · cites it directly · 0 of its ownK230773 Endoscopy Irrigation TubingZhejiang Chuangxiang Medical Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK223171 AquaPulse® Irrigation TubingGa Health Company Limited · 2022
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 | K884836 | Universal Generator Irrigator Model Ugi-3000 | Meditron Devices, Inc. | 1988 | — |
| −2 | K031773 | Endo Gator System | Byrne Medical, Inc. | 2003 | — |
| −1 | K092429 | Endogator | Byrne Medical, Inc. | 2009 | — |
| 0 (this device) | K202560 | AquaPulse Irrigation Tubing | Ga Health Company Limited | 2020 | — |
| +1 | K230773 | Endoscopy Irrigation Tubing | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023 | — |
| +1 | K223171 | AquaPulse® Irrigation Tubing | Ga Health Company Limited | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K092429 | EndogatorSummary page 4…cation: 2 Device Panel: Gastroenterology/Urology 5. Predicate Device Identification Predicate Device 510(k) No.: K092429 Predicate Device Trade Name: EndoGator Predicate Device Product Code: FEQ 6. Device Description: Th… | 2009 |
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 32 years and passes through 3 companies; a new generation was cleared every 11.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K230773 (Zhejiang Chuangxiang Medical Technology Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 12 other devices also cite its predicate K092429.
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 24 hour use AquaPulse® Irrigation Tubing (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202560: AquaPulse Irrigation Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202560
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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