510(k) · Cleared
ClearedDisposable Endoscope Valves System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou Endoclean Medical Device Co., Ltd. · ODC Endoscope Channel Accessory
Cleared on Sep 8, 2022 as substantially equivalent to K090851 (Byrne Medical, Inc., 2009) and 2 other predicates after a 126-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Sep 8, 2022
- Review
- 126 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K884836 (1988). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK884836 Universal Generator Irrigator Model Ugi-3000Meditron Devices, Inc. · 1988
- 3 generations backK031773 Endo Gator SystemByrne Medical, Inc. · 2003
- 2 generations backK092429 EndogatorByrne Medical, Inc. · 2009
- 1 generation backK200769 Disposable Endoscope Valves Set, Disposable Endoscope Valves Set BWilson Instruments (Sha) Co., Ltd. · 2021
- This deviceK221331 Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K884836 | Universal Generator Irrigator Model Ugi-3000 | Meditron Devices, Inc. | 1988 | — |
| −3 | K031773 | Endo Gator System | Byrne Medical, Inc. | 2003 | — |
| −2 | K092429 | Endogator | Byrne Medical, Inc. | 2009 | — |
| −1 | K200769 | Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B | Wilson Instruments (Sha) Co., Ltd. | 2021 | — |
| 0 (this device) | K221331 | Disposable Endoscope Valves System | Changzhou Endoclean Medical Device Co., Ltd. | 2022 | — |
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 14.0 · 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 |
|---|---|---|---|
| * | K090851 | Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model 100301…Summary page 5…Page 2 of 8 510(k) summary-K221331 III. Predicate Devices a. 510(k) Number: K090851 Common name: Endoscopes and accessories Classification: 21 CFR 876.1500 Product Code: ODC Trade name: DEFENDOTM Biops… | 2009 |
| * | K200769 | Disposable Endoscope Valves Set, Disposable Endoscope Valves Set BSummary page 5…or Olympus and Fujinon Endoscopes DEFENDOTM Biopsy Valve for Pentax Endoscopes Manufacturer: Medivators Inc formerly Byrne Medical b. 510(k) Number: K200769 Product Code: ODC Classification: 21 CFR 876.1500 Trade Name: Disposable Endoscope Valves Set, Disposab… | 2021 |
| * | K102409 | Defendo Disposable Air/Water Valve Model 100304Summary page 5…Trade Name: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B Manufacturer: Wilson Instruments (SHA) Co., LTD. c. 510(k) Number: K102409 Product Code: ODC Classification: 21 CFR 876.1500 Trade Name: DEFENDOTM Disposable Air/Water Valve for GI Endoscopes… | 2010 |
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 34 years and passes through 4 companies; a new generation was cleared every 11.1 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 8 other devices also cite its predicate K090851.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 System includes an air/water valve, a suction valve, a biopsy valve and a water connector. Disposable Biopsy Valve, it is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. Disposable Air/Water Valve, it is intended to be fitted to an endoscope Air/water channel to enable…
Read the full statement (119 words)
The Disposable Endoscope Valves System includes an air/water valve, a suction valve, a biopsy valve and a water connector.
Disposable Biopsy Valve, it is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure.
Disposable Air/Water Valve, it is intended to be fitted to an endoscope Air/water channel to enable the operator to control inflow of medical gases and water.
Disposable Suction Valve, it is intended to be fitted to an endoscope suction channel to enable the operator to control suction.
Water Jet Connector, it is intended to prevent liquid backflow when providing sterile water to the endoscope during endoscopic surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221331: Disposable Endoscope Valves System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221331
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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