510(k) · Cleared
ClearedEndoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · ODC Endoscope Channel Accessory
Cleared on Mar 22, 2018 as substantially equivalent to K091838 (Obp Medical, 2009) and 1 other predicate after a 174-day review. Its family tree reaches back 2 generations to 1992. 3 later devices descend from it.
- Decided
- Mar 22, 2018
- Review
- 174 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K920030 (1992). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK920030 Sureseal Endoscopic ValveApplied Urology, Inc. · 1992
- 1 generation backK130909 Gateway Advanage Y-AdapterBoston Scientific Corp · 2013
- This deviceK173105 Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst…Cook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK252933 Dyne PortDyne Medical Group, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK241842 Luer-Split MAJ-2092Olympus Medical Systems Corporation · 2025
- Descendant · cites it directly · 0 of its ownK181712 San Antonio StopcockCook Incorporated · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920030 | Sureseal Endoscopic Valve | Applied Urology, Inc. | 1992 | — |
| −1 | K130909 | Gateway Advanage Y-Adapter | Boston Scientific Corp | 2013 | — |
| 0 (this device) | K173105 | Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter | Cook Incorporated | 2018 | — |
| +1 | K252933 | Dyne Port | Dyne Medical Group, Inc. | 2026 | — |
| +1 | K241842 | Luer-Split MAJ-2092 | Olympus Medical Systems Corporation | 2025 | — |
| +1 | K181712 | San Antonio Stopcock | Cook Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 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 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? (2)
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 |
|---|---|---|---|
| * | K091838 | Obp Self Sealing Endoscopic Seal with Luer LockSummary page 4…Code ODC Device Class/Classification Panel: Class II, Gastroenterology/Urology Predicate Device: Primary predicate device: OBP Self Sealing Endoscopic Seal (K091838). Secondary predicate device: Gateway™ Advantage Y-Adapter (K130909) Device Description: The Endoscopic Cap covers fem… | 2009 |
| * | K130909 | Gateway Advanage Y-AdapterSummary page 4…rology Predicate Device: Primary predicate device: OBP Self Sealing Endoscopic Seal (K091838). Secondary predicate device: Gateway™ Advantage Y-Adapter (K130909) Device Description: The Endoscopic Cap covers female Luer locks and bulb-type endoscopic fittings. The Endoscopic Cap is con… | 2013 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 years and passes through 3 companies; a new generation was cleared every 21.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K252933 (Dyne Medical Group, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K091838.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
This device is intended to resist the backflow of fluid around an instrument inserted through the working channel of a ureteroscope, cystoscope, or other endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173105: Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173105
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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