510(k) · Cleared
ClearedDisposable Endoscope Valves Set, Disposable Endoscope Valves Set B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson Instruments (Sha) Co., Ltd. · ODC Endoscope Channel Accessory
Cleared on Jan 6, 2021 as substantially equivalent to K102409 (Byrne Medical, Inc., 2010) and 3 other predicates after a 287-day review. Its family tree reaches back 3 generations to 1988. 7 later devices descend from it.
- Decided
- Jan 6, 2021
- Review
- 287 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. 7 later devices descend from it, 3 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 deviceK200769 Disposable Endoscope Valves Set, Disposable Endoscope Valves Set BWilson Instruments (Sha) Co., Ltd. · 2021
- Descendant · cites it directly · 3 of its ownK220210 Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK220884 Disposable Endoscope Valve SetsSml Med-Tech Solutions Limited · 2023
- Descendant · 2 generations on · 0 of its ownK250732 Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK241285 Disposable Endoscope Valves Set (AF series)Alton (Shanghai) Medical Instruments Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK222499 Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co., Ltd. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K220210Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022 · cites it directly3descendants
- K220884Disposable Endoscope Valve SetsSml Med-Tech Solutions Limited · 2023 · cites it directly1descendant
- K250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K241285Disposable Endoscope Valves Set (AF series)Alton (Shanghai) Medical Instruments Co., Ltd. · 2024 · 2 generations on0descendants
- K222499Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co., Ltd. · 2023 · 2 generations on0descendants
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) | K200769 | Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B | Wilson Instruments (Sha) Co., Ltd. | 2021 | — |
| +1 | K220210 | Disposable Endoscopy Adapter Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022 | — |
| +1 | K220884 | Disposable Endoscope Valve Sets | Sml Med-Tech Solutions Limited | 2023 | — |
| +2 | K250732 | Disposable Endoscopy Valve Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2025 | — |
| +2 | K241285 | Disposable Endoscope Valves Set (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2024 | — |
| +2 | K222499 | Disposable Endoscope Valves Kit | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 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 |
|---|---|---|
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 14.1 · 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 |
|---|---|---|---|
| * | K102409 | Defendo Disposable Air/Water Valve Model 100304Summary page 4…for GI Endoscopes Common name: Endoscopes and accessories Classification: Class II, 21 CFR 876.1500 Product Code: ODC Premarket Notification: K102409 Manufacturer: Medivators Inc formerly Byrne Medical Trade name: DEFENDOTM Disposable Suction Valve for GI… | 2010 |
| * | K102581 | Defendo Disposable Suction Valve Model 100305Summary page 4…GI Endoscopes Common name: Endoscopes and accessories Classification: Class II, 21 CFR 876.1500 Product Code: ODC, FDF Premarket Notification: K102581 Manufacturer: Medivators Inc formerly Byrne Medical Trade name: DEFENDOTM Biopsy Valve for Olympus and Fuj… | 2010 |
| * | K090851 | Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model 100301…Summary page 5…Page 2 of 11 pages Common name: Endoscopes and accessories Classification: Class II, 21 CFR 876.1500 Product Code: ODC Premarket Notification: k090851 Manufacturer: Medivators Inc formerly Byrne Medical Trade name: EndoGatorTM System Common name: En… | 2009 |
| * | K092429 | EndogatorSummary page 5…EndoGatorTM System Common name: Endoscopes and accessories Classification: Class II, 21 CFR 876.1500 Product Code: FEQ Premarket Notification: k092429 Manufacturer: Medivators Inc formerly Byrne Medical IV. Device description The Disposable Endoscope Valves Set is a col… | 2009 |
What descends from it? (7)
3 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 33 years and passes through 3 companies; a new generation was cleared every 11.1 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K220210 (Yangzhou Fartley Medical Instrument Technology Co., Ltd., 2022) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K102409.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an air/water valve, a suction valve, a biopsy valve and a water connector. - Disposable Air/Water Valves: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst…
Read the full statement (272 words)
The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
- Disposable Air/Water Valves: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
- Disposable Suction Valves: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
- Disposable Biopsy Valves: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
- Disposable Endoscope Water Connectors: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve, an air/water valve. This is a single-use device.
- Air/Water Valves: This device is intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow.
- Suction Valves: The device is intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200769 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200769: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200769
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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