510(k) · Cleared
ClearedSeal Single-Use Biopsy Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endochoice, Inc. · OCX Endoscopic Irrigation/Suction System
Cleared on May 26, 2016 as substantially equivalent to K133734 (Endochoice, Inc., 2014) after a 30-day review. Its family tree reaches back 2 generations to 2011. 3 later devices descend from it.
- Decided
- May 26, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K111821 (2011). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK111821 Biopsy ValveEndochoice, Inc. · 2011
- 1 generation backK133734 Seal Single-Use Biopsy ValveEndochoice, Inc. · 2014
- This deviceK161167 Seal Single-Use Biopsy ValveEndochoice, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK182275 Seal Single Use Biopsy ValveBoston Scientific Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK251997 Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems Corporation · 2025
- Descendant · cites it directly · 0 of its ownK173758 Disposable Biopsy ValveZhejiang Chuangxiang Medical Technology Co., Ltd. · 2018
Most influential descendants
Showing 3 of 3 · See all- K182275Seal Single Use Biopsy ValveBoston Scientific Corporation · 2018 · cites it directly1descendant
- K251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems Corporation · 2025 · 2 generations on0descendants
- K173758Disposable Biopsy ValveZhejiang Chuangxiang Medical Technology Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K111821 | Biopsy Valve | Endochoice, Inc. | 2011 | — |
| −1 | K133734 | Seal Single-Use Biopsy Valve | Endochoice, Inc. | 2014 | — |
| 0 (this device) | K161167 | Seal Single-Use Biopsy Valve | Endochoice, Inc. | 2016 | — |
| +1 | K182275 | Seal Single Use Biopsy Valve | Boston Scientific Corporation | 2018 | — |
| +2 | K251997 | Single-Use Biopsy Valve (MAJ-1555) | Olympus Medical Systems Corporation | 2025 | — |
| +1 | K173758 | Disposable Biopsy Valve | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K133734 | Seal Single-Use Biopsy ValveSummary page 5…flow from the endoscope, and out of the biopsy valve. 7. Substantial Equivalence: The device submitted for review is a modification of the Biopsy Valve (K133734). Changes to the device include a modification in material. Both the modified and unmodified device is composed of th… | 2014 |
What descends from it? (3)
2 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 5 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K182275 (Boston Scientific Corporation, 2018) has gone furthest, with 1 descendant 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. 2016, 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 Single-Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from biopsy port throughout the endoscopic procedure, and provides access for irrigation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161167: Seal Single-Use Biopsy Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161167
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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