510(k) · Cleared
ClearedANDORATE® Valve Kit
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 Jul 7, 2023 as substantially equivalent to K181509 (Smartdata Suzhou Co., Ltd., 2018) and 2 other predicates after a 95-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- Jul 7, 2023
- Review
- 95 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K884836 (1988). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK884836 Universal Generator Irrigator Model Ugi-3000Meditron Devices, Inc. · 1988
- 4 generations backK031773 Endo Gator SystemByrne Medical, Inc. · 2003
- 3 generations backK092429 EndogatorByrne Medical, Inc. · 2009
- 2 generations backK110088 Defendo Y-Opsy IrrigatorByrne Medical Incorporated · 2011
- 1 generation backK200481 Andorate Biopsy Valve, Andorate Biopsy IrrigatorGa Health Company Limited · 2020
- This deviceK230932 ANDORATE® Valve KitGa Health Company Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K884836 | Universal Generator Irrigator Model Ugi-3000 | Meditron Devices, Inc. | 1988 | — |
| −4 | K031773 | Endo Gator System | Byrne Medical, Inc. | 2003 | — |
| −3 | K092429 | Endogator | Byrne Medical, Inc. | 2009 | — |
| −2 | K110088 | Defendo Y-Opsy Irrigator | Byrne Medical Incorporated | 2011 | — |
| −1 | K200481 | Andorate Biopsy Valve, Andorate Biopsy Irrigator | Ga Health Company Limited | 2020 | — |
| 0 (this device) | K230932 | ANDORATE® Valve Kit | Ga Health Company Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2009 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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? (3)
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 |
|---|---|---|---|
| * | K181509 | Endorate Valve SetsSummary page 4…2 Device Panel: Gastroenterology/Urology 5. Predicate Device Identification Primary Predicate Device 510(k) No.: K181509 Primary Predicate Device Trade Name: Endorate Valve Sets Primary Predicate Device Product Code: ODC - Endoscope C… | 2018 |
| * | K200481 | Andorate Biopsy Valve, Andorate Biopsy IrrigatorSummary page 4…evice Trade Name: Endorate Valve Sets Primary Predicate Device Product Code: ODC - Endoscope Channel Accessory Secondary Predicate Device 510(k) No.: K200481 Secondary Predicate Device Trade Name: Biopsy Valve Secondary Predicate Device Product Code: ODC - Endoscope Channel… | 2020 |
| * | K182998 | Andorate Auxiliary Water ConnectorSummary page 4…edicate Device Trade Name: Biopsy Valve Secondary Predicate Device Product Code: ODC - Endoscope Channel Accessory Secondary Predicate Device 510(k) No.: K182998 Secondary Predicate Device Trade Name: Andorate Auxiliary Water Connector Secondary Predicate Device Product Code: OC… | 2019 |
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 35 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- 3 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K181509.
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 single use ANDORATE® Air/Water Valve is used to control the air / water function of an endoscope during GI endoscopic procedures. The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during GI endoscopic procedures. The single use ANDORATE® Biopsy Valve is used to cover the opening to the biopsy/suction channel of Olympus® gastro-intestinal endoscopes. The Biopsy Valve provides access for endoscopic device…
Read the full statement (156 words)
The single use ANDORATE® Air/Water Valve is used to control the air / water function of an endoscope during GI endoscopic procedures.
The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during GI endoscopic procedures.
The single use ANDORATE® Biopsy Valve is used to cover the opening to the biopsy/suction channel of Olympus® gastro-intestinal endoscopes. The Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure and provides access for irrigation.
The single use ANDORATE® Auxiliary Water Connector is used in conjunction with irrigation tubing, intended to provide irrigation via irrigation fluids such as sterile water supplied to the Olympus® GI endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump. The Auxiliary Water Connector is manufactured with a one-way valve to minimize the risk of cross-contamination of the irrigation system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230932 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230932: ANDORATE® Valve Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230932
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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