510(k) · Cleared
ClearedBiopsy 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 Jul 28, 2011 after a 30-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Jul 28, 2011
- Review
- 30 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK111821 Biopsy ValveEndochoice, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK133734 Seal Single-Use Biopsy ValveEndochoice, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK161167 Seal Single-Use Biopsy ValveEndochoice, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK182275 Seal Single Use Biopsy ValveBoston Scientific Corporation · 2018
- Descendant · cites it directly · 1 of its ownK152140 Boa Endoscopic ValveC2 Therapeutics, Inc. · 2015
- Descendant · 4 generations on · 0 of its ownK251997 Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems Corporation · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K133734Seal Single-Use Biopsy ValveEndochoice, Inc. · 2014 · cites it directly4descendants
- K161167Seal Single-Use Biopsy ValveEndochoice, Inc. · 2016 · 2 generations on3descendants
- K182275Seal Single Use Biopsy ValveBoston Scientific Corporation · 2018 · 3 generations on1descendant
- K152140Boa Endoscopic ValveC2 Therapeutics, Inc. · 2015 · cites it directly1descendant
- K251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems Corporation · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111821 | Biopsy Valve | Endochoice, Inc. | 2011 | — |
| +1 | K133734 | Seal Single-Use Biopsy Valve | Endochoice, Inc. | 2014 | — |
| +2 | K161167 | Seal Single-Use Biopsy Valve | Endochoice, Inc. | 2016 | — |
| +3 | K182275 | Seal Single Use Biopsy Valve | Boston Scientific Corporation | 2018 | — |
| +1 | K152140 | Boa Endoscopic Valve | C2 Therapeutics, Inc. | 2015 | — |
| +4 | K251997 | Single-Use Biopsy Valve (MAJ-1555) | Olympus Medical Systems Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 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 |
|---|---|---|---|
| * | — | US Endloscopy - Bioshield - ERCP Biopsy Valve Named without a submission number |
What descends from it? (9)
4 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?
- Of its descendants, K133734 (Endochoice, Inc., 2014) has gone furthest, with 4 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. 2011, 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?
Biopsy valves are intended to provide access for endloscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomnaterial from the biopsy port throughout the endloscopic procedure, and provides access for irrigation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111821: 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/K111821
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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