510(k) · Cleared
ClearedDisposable Endoscope Valves Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai SeeGen Photoelectric Technology Co., Ltd. · ODC Endoscope Channel Accessory
Cleared on Nov 22, 2023 as substantially equivalent to K220210 (Yangzhou Fartley Medical Instrument Technology Co., Ltd., 2022) after a 461-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- Nov 22, 2023
- Review
- 461 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K884836 (1988). 11 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 backK200769 Disposable Endoscope Valves Set, Disposable Endoscope Valves Set BWilson Instruments (Sha) Co., Ltd. · 2021
- 1 generation backK220210 Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022
- This deviceK222499 Disposable Endoscope Valves KitShanghai SeeGen Photoelectric Technology Co., Ltd. · 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 | 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 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K220210 | Disposable Endoscopy Adapter SetSummary page 6…n Name： Endoscope and Accessories Product Code: ODC 5.3 Predicate Device Device Name: Disposable Endoscopy Adapter Set, K220210 Common Name: Endoscope Channel Accessory Regulatory Class: Class II Regulation Number:… | 2022 |
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 5 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 2 other devices also cite its predicate K220210.
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 values are used in conjunction with conventional gastrointestinal endoscope to control the functions of water/gas injection and suction during the endoscopic operation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222499 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222499: Disposable Endoscope Valves Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222499
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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