510(k) · Cleared
ClearedAndorate Auxiliary Water Connector, Andorate Valves Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smartdata Suzhou Co., Ltd. · ODC Endoscope Channel Accessory
Cleared on Jun 7, 2019 as substantially equivalent to K092429 (Byrne Medical, Inc., 2009) and 3 other predicates after a 30-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it.
- Decided
- Jun 7, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K884836 (1988). 9 ancestors in all. 1 later device descends from it, 1 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 deviceK191231 Andorate Auxiliary Water Connector, Andorate Valves SetSmartdata Suzhou Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK232118 ANDORATE® Valve KitGa Health Company Limited · 2023
Most influential descendants
Showing 1 of 1 · See all- K232118ANDORATE® Valve KitGa Health Company Limited · 2023 · cites it directly0descendants
View 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) | K191231 | Andorate Auxiliary Water Connector, Andorate Valves Set | Smartdata Suzhou Co., Ltd. | 2019 | — |
| +1 | K232118 | 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 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (4)
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…ccessories Regulation Number: 21 CFR 876.1500 Classification: II 5. Predicate Device Identification Predicate Device 510(k) No.: K092429 Predicate Device Trade Name: ENDOGATOR Predicate Device Product Code: FEQ Predicate Device 510(k) No.… | 2009 |
| * | K102581 | Defendo Disposable Suction Valve Model 100305Summary page 4…10(k) No.: K092429 Predicate Device Trade Name: ENDOGATOR Predicate Device Product Code: FEQ Predicate Device 510(k) No.: K102581 Predicate Device Trade Name: DEFENDOTM Disposable Suction Valve Predicate Device Product Code: ODC Pr… | 2010 |
| * | K102409 | Defendo Disposable Air/Water Valve Model 100304Summary page 4…581 Predicate Device Trade Name: DEFENDOTM Disposable Suction Valve Predicate Device Product Code: ODC Predicate Device 510(k) No.: K102409 Predicate Device Trade Name: DEFENDOTM Disposable Air/Water Valve Predicate Device Product Code: ODC… | 2010 |
| * | K090851 | Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model 100301…Summary page 4…9 Predicate Device Trade Name: DEFENDOTM Disposable Air/Water Valve Predicate Device Product Code: ODC Predicate Device 510(k) No.: K090851 Predicate Device Trade Name: DEFENDOTM Disposable Biopsy Valve Predicate Device Product Code: ODC === Pa… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232118 | ANDORATE® Valve Kit | 2023 | 0 |
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 3 companies; a new generation was cleared every 9.5 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K232118 (Ga Health Company Limited, 2023) has gone furthest, with 0 descendants of its own.
- 12 other devices also cite its predicate K092429.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Andorate Auxiliary Water Connector (Model GAR048) is used in conjunction with irrigation tubing (not supplied), intended to provide irrigation via irrigation fluids such as sterile water supplied to the Pentax 90 series endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump. The disposable Andorate Valves Set (Model GAR037) consists of one suction valve, one air/water valve and one biopsy valve. - The…
Read the full statement (163 words)
The Andorate Auxiliary Water Connector (Model GAR048) is used in conjunction with irrigation tubing (not supplied),
intended to provide irrigation via irrigation fluids such as sterile water supplied to the Pentax 90 series endoscope during
gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
The disposable Andorate Valves Set (Model GAR037) consists of one suction valve, one air/water valve and one biopsy
valve.
- The Andorate Disposable Suction Valve is used to control the suction function of an endoscope (for Pentax 90 series
Endoscope) during a GI Endoscopic procedure.
- The Andorate Disposable Air/Water valve is used to control the air/water function of an endoscope (for Pentax 90 series
Endoscope) during a GI Endoscopic procedure.
- The Andorate Disposable biopsy valve is used to cover the endoscope biopsy port during an endoscopy procedure. In
addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and
minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191231: Andorate Auxiliary Water Connector, Andorate Valves Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191231
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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