510(k) · Cleared
ClearedSeal Biopsy Valve - Reusable
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 Dec 20, 2013 as substantially equivalent to K111821 (Endochoice, Inc., 2011) after a 106-day review. Its family tree reaches back 1 generation to 2011.
- Decided
- Dec 20, 2013
- Review
- 106 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K111821 (2011). No later device cites it as a predicate yet.
- Root · 1 generation backK111821 Biopsy ValveEndochoice, Inc. · 2011
- This deviceK132776 Seal Biopsy Valve - ReusableEndochoice, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K111821 | Biopsy Valve | Endochoice, Inc. | 2011 | — |
| 0 (this device) | K132776 | Seal Biopsy Valve - Reusable | Endochoice, Inc. | 2013 | — |
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 |
|---|---|---|---|
| * | K111821 | Biopsy ValveSummary page 2…osed labeling). 7. Substantial Equivalence 7.1. Predicate devices The Seal reusable biopsy valve is substantially equivalent to the Seal Single Use biopsy valve (KI 111821) manufactured by EndoChoice. The intended use, design, materials and labeling are all substantially equivalent. 7.2. Intende… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 3 other devices also cite its predicate K111821.
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 device is intended to provide access for endoscopic device passage and exchange, helps maintain Insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132776 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132776: Seal Biopsy Valve - Reusable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132776
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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