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 · ODC Endoscope Channel Accessory
Cleared on Oct 16, 2023 as substantially equivalent to K191231 (Smartdata Suzhou Co., Ltd., 2019) and 2 other predicates after a 91-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Oct 16, 2023
- Review
- 91 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K944759 (1995). 20 ancestors in all, the oldest K884836 (1988). No later device cites it as a predicate yet.
- Root · 7 generations backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
- 6 generations backK041903 Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc. · 2004 · Recalled
- 5 generations backK112391 Fujinon ColonoscopesFujinon, Inc. · 2012
- 4 generations backK132210 Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc. · 2014
- 3 generations backK160196 Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc. · 2016
- 2 generations backK172916 FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and…Fujifilm Corporation · 2018
- 1 generation backK200495 Andorate Disposable Air/Water Valve, Andorate Disposable Suction ValveGa Health Company Limited · 2020
- This deviceK232118 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 |
|---|---|---|---|---|---|
| −7 | K944759 | 200 Series Gastro-Intestinal Video System | Fujinon, Inc. | 1995 | 5 |
| −6 | K041903 | Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5 | Fujinon, Inc. | 2004 | 1 |
| −5 | K112391 | Fujinon Colonoscopes | Fujinon, Inc. | 2012 | — |
| −4 | K132210 | Fujifilm 600 Series Endoscopes | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
| −3 | K160196 | Fujifilm Video Colonoscope Model EC-600WL V2 | Fujifilm Medical Systems U.S.A, Inc. | 2016 | — |
| −2 | K172916 | FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and… | Fujifilm Corporation | 2018 | — |
| −1 | K200495 | Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve | Ga Health Company Limited | 2020 | — |
| 0 (this device) | K232118 | ANDORATE® Valve Kit | Ga Health Company Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 ODC? 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 ODC device
- #1 K232329 Defendo Fujifilm 700 Single Use Biopsy Valve…score 14.0 · 6 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 |
|---|---|---|---|
| * | K191231 | Andorate Auxiliary Water Connector, Andorate Valves SetSummary page 5…2 Device Panel: Gastroenterology/Urology 5. Predicate Device Identification Primary Predicate Device 510(k) No.: K191231 Primary Predicate Device Trade Name: Andorate Auxiliary Water Connector, Andorate… | 2019 |
| * | K200495 | Andorate Disposable Air/Water Valve, Andorate Disposable Suction ValveSummary page 5…ODC - Endoscope Channel Accessory OCX - Endoscopic Irrigation/Suction System Secondary Predicate Device 510(k) No.: K200495 Secondary Predicate Device Trade Name: Andorate Disposable Air/Water Valve,… | 2020 |
| * | K200479 | AquaPulse Auxiliary Water ConnectorSummary page 5…Andorate Disposable Suction Valve Secondary Predicate Device Product Code: ODC - Endoscope Channel Accessory Secondary Predicate Device 510(k) No.: K200479 510(k) Summary… | 2020 |
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 28 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 20 ancestors have a recall of any class.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · ODC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODC
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODC
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODC
91in 2025
MAUDE reports naming product code ODC, 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 | 3 | 83 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 67 | 0 | 0 |
| 2011 | 4 | 143 | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 8 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 4 | 55 | 0 | 40 |
| 2020 | 4 | 128 | 0 | 54 |
| 2021 | 6 | 181 | 0 | 52 |
| 2022 | 8 | 118 | 0 | 37 |
| 2023 | 7 | 126 | 0 | 43 |
| 2024 | 8 | 95 | 0 | 100 |
| 2025 | 6 | 106 | 0 | 91 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during GI endoscopic procedures. 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® Biopsy Valve is used to cover the opening to the biopsy/suction channel of gastro-intestinal endoscopes. The Biopsy Valve provides access for endoscopic device passage and…
Read the full statement (154 words)
The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during GI endoscopic procedures.
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® Biopsy Valve is used to cover the opening to the biopsy/suction channel of 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 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/K232118 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232118: 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/K232118
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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