510(k) · Cleared
ClearedGateway Advanage Y-Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · OCX Endoscopic Irrigation/Suction System
Cleared on May 16, 2013 as substantially equivalent to K920030 (Applied Urology, Inc., 1992) after a 45-day review. Its family tree reaches back 1 generation to 1992. 4 later devices descend from it.
- Decided
- May 16, 2013
- Review
- 45 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920030 (1992). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK920030 Sureseal Endoscopic ValveApplied Urology, Inc. · 1992
- This deviceK130909 Gateway Advanage Y-AdapterBoston Scientific Corp · 2013
- Descendant · cites it directly · 3 of its ownK173105 Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst…Cook Incorporated · 2018
- Descendant · 2 generations on · 0 of its ownK252933 Dyne PortDyne Medical Group, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241842 Luer-Split MAJ-2092Olympus Medical Systems Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK181712 San Antonio StopcockCook Incorporated · 2018
Most influential descendants
Showing 4 of 4 · See all- K173105Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst AdapterCook Incorporated · 2018 · cites it directly3descendants
- K252933Dyne PortDyne Medical Group, Inc. · 2026 · 2 generations on0descendants
- K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation · 2025 · 2 generations on0descendants
- K181712San Antonio StopcockCook Incorporated · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920030 | Sureseal Endoscopic Valve | Applied Urology, Inc. | 1992 | — |
| 0 (this device) | K130909 | Gateway Advanage Y-Adapter | Boston Scientific Corp | 2013 | — |
| +1 | K173105 | Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter | Cook Incorporated | 2018 | — |
| +2 | K252933 | Dyne Port | Dyne Medical Group, Inc. | 2026 | — |
| +2 | K241842 | Luer-Split MAJ-2092 | Olympus Medical Systems Corporation | 2025 | — |
| +2 | K181712 | San Antonio Stopcock | Cook Incorporated | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 OCX? 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 OCX device
- #1 K251986 Auxiliary Water Tube Maj-855score 12.8 · 10 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 |
|---|---|---|---|
| * | K920030 | Sureseal Endoscopic ValveSummary page 1…Name: KOG - Endoscope and accessories Premarket Notification: Applied Medical Sureseal 11 (formerly Applied Urology, Inc. Sureseal Endoscopic Valve), K920030, March 18, 1992. E. Device Description The Gateway Advantage Y-Adapter has four main components; 1) a rotatable mal… | 1992 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173105 | Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter | 2018 | 3 |
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?
- Its one ancestor has no recall.
- Of its descendants, K173105 (Cook Incorporated, 2018) has gone furthest, with 3 descendants of its own.
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OCX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCX
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCX
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCX
33in 2025
MAUDE reports naming product code OCX, 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 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 51 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 4 | 256 | 0 | 1 |
| 2013 | 3 | 106 | 0 | 1 |
| 2014 | 6 | 77 | 0 | 5 |
| 2015 | 2 | — | 1 | 9 |
| 2016 | 2 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 5 | 60 | 0 | 18 |
| 2019 | 8 | 133 | 0 | 41 |
| 2020 | 4 | 88 | 11 | 11 |
| 2021 | 3 | 233 | 0 | 8 |
| 2022 | 6 | 84 | 2 | 18 |
| 2023 | 7 | 109 | 0 | 46 |
| 2024 | 4 | 74 | 0 | 21 |
| 2025 | 4 | 178 | 0 | 33 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Gateway Advantage Y-Adapter is intended to prevent irrigant backflow while securing urological devices during procedures.. Irrigation may also be connected to the side port of the device. The Y-Adapter is supplied in a sealed pouch and is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130909 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130909: Gateway Advanage Y-Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130909
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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