510(k) · Cleared
ClearedSureseal Endoscopic Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Urology, Inc. · ODC Endoscope Channel Accessory
Cleared on Mar 18, 1992 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Mar 18, 1992
- Review
- 75 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK920030 Sureseal Endoscopic ValveApplied Urology, Inc. · 1992
- Descendant · cites it directly · 4 of its ownK130909 Gateway Advanage Y-AdapterBoston Scientific Corp · 2013
- Descendant · 2 generations on · 3 of its ownK173105 Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst…Cook Incorporated · 2018
- Descendant · 3 generations on · 0 of its ownK252933 Dyne PortDyne Medical Group, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK241842 Luer-Split MAJ-2092Olympus Medical Systems Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK181712 San Antonio StopcockCook Incorporated · 2018
Most influential descendants
Showing 5 of 5 · See all- K130909Gateway Advanage Y-AdapterBoston Scientific Corp · 2013 · cites it directly4descendants
- K173105Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst AdapterCook Incorporated · 2018 · 2 generations on3descendants
- K252933Dyne PortDyne Medical Group, Inc. · 2026 · 3 generations on0descendants
- K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation · 2025 · 3 generations on0descendants
- K181712San Antonio StopcockCook Incorporated · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920030 | Sureseal Endoscopic Valve | Applied Urology, Inc. | 1992 | — |
| +1 | K130909 | Gateway Advanage Y-Adapter | Boston Scientific Corp | 2013 | — |
| +2 | K173105 | Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter | Cook Incorporated | 2018 | — |
| +3 | K252933 | Dyne Port | Dyne Medical Group, Inc. | 2026 | — |
| +3 | K241842 | Luer-Split MAJ-2092 | Olympus Medical Systems Corporation | 2025 | — |
| +3 | K181712 | San Antonio Stopcock | Cook Incorporated | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130909 | Gateway Advanage Y-Adapter | 2013 | 4 |
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?
- Of its descendants, K130909 (Boston Scientific Corp, 2013) has gone furthest, with 4 descendants of its own.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K920030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920030: Sureseal Endoscopic Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920030
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026