510(k) · Cleared
ClearedSingle Use Endoscope Valves Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anrei Medical (Hangzhou) Co., Ltd. · ODC Endoscope Channel Accessory
Cleared on May 14, 2020 as substantially equivalent to K102409 (Byrne Medical, Inc., 2010) and 2 other predicates after a 288-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- May 14, 2020
- Review
- 288 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K001241 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK001241 Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/IThe Olympus Optical Co. · 2000 · Recalled
- 1 generation backK102409 Defendo Disposable Air/Water Valve Model 100304Byrne Medical, Inc. · 2010
- This deviceK192048 Single Use Endoscope Valves SetAnrei Medical (Hangzhou) Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001241 | Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I | The Olympus Optical Co. | 2000 | 1 |
| −1 | K102409 | Defendo Disposable Air/Water Valve Model 100304 | Byrne Medical, Inc. | 2010 | — |
| 0 (this device) | K192048 | Single Use Endoscope Valves Set | Anrei Medical (Hangzhou) Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K102409 | Defendo Disposable Air/Water Valve Model 100304Summary page 6…e same indication for use, materials and components form. 3-2 K192048 Page 3 of 9 510(k) Summary Identification of Predicate Device(s) 510(k) Number: K102409 Product Name: DEFENDO Disposable Air/Water Valve for GI Endoscopes 510(k) Number: K102581 Product Name: DEFENDO Disposable Sucti… | 2010 |
| * | K102581 | Defendo Disposable Suction Valve Model 100305Summary page 6…3 of 9 510(k) Summary Identification of Predicate Device(s) 510(k) Number: K102409 Product Name: DEFENDO Disposable Air/Water Valve for GI Endoscopes 510(k) Number: K102581 Product Name: DEFENDO Disposable Suction Valve for GI Endoscopes 510(k) Number: K090851 Product Name: DEFENDO Biopsy Valve (Mode… | 2010 |
| * | K090851 | Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model 100301…Summary page 6…oduct Name: DEFENDO Disposable Air/Water Valve for GI Endoscopes 510(k) Number: K102581 Product Name: DEFENDO Disposable Suction Valve for GI Endoscopes 510(k) Number: K090851 Product Name: DEFENDO Biopsy Valve (Model #100301 and 100302) Non-Clinical Test Discussion Non clinical tests were conducted to… | 2009 |
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 20 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 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. 2020, 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 Endoscope Valves Set are used to fit to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials.
The Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
The Biopsy Valve is intended to accommodate various sizes of endoscopic accessory instruments while still providing a seal around the instrument channel inlet.
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/K192048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192048: Single Use Endoscope 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/K192048
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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