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
Boston Scientific Corporation · OCX Endoscopic Irrigation/Suction System
Cleared on Sep 13, 2018 as substantially equivalent to K161167 (Endochoice, Inc., 2016) after a 22-day review. Its family tree reaches back 3 generations to 2011. 1 later device descends from it.
- Decided
- Sep 13, 2018
- Review
- 22 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K111821 (2011). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK111821 Biopsy ValveEndochoice, Inc. · 2011
- 2 generations backK133734 Seal Single-Use Biopsy ValveEndochoice, Inc. · 2014
- 1 generation backK161167 Seal Single-Use Biopsy ValveEndochoice, Inc. · 2016
- This deviceK182275 Seal Single Use Biopsy ValveBoston Scientific Corporation · 2018
- Descendant · cites it directly · 0 of its ownK251997 Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems Corporation · 2025
Most influential descendants
Showing 1 of 1 · See all- K251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K111821 | Biopsy Valve | Endochoice, Inc. | 2011 | — |
| −2 | K133734 | Seal Single-Use Biopsy Valve | Endochoice, Inc. | 2014 | — |
| −1 | K161167 | Seal Single-Use Biopsy Valve | Endochoice, Inc. | 2016 | — |
| 0 (this device) | K182275 | Seal Single Use Biopsy Valve | Boston Scientific Corporation | 2018 | — |
| +1 | K251997 | Single-Use Biopsy Valve (MAJ-1555) | Olympus Medical Systems Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K161167 | Seal Single-Use Biopsy ValveSummary page 4…tion Number: 876.1500 Endoscope and Accessories Product Code: OCX Classification: Class II 3. Predicate Device: Trade Name: Seal™ Single Use Biopsy Valve 510(k) Number: K161167 Classification Name: Endoscopic Irrigation/Suction System Regulation Number: 876.1500 Endoscope and Accessories Product Code: OCX… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251997 | Single-Use Biopsy Valve (MAJ-1555) | 2025 | 0 |
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 7 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K251997 (Olympus Medical Systems Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K161167.
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Seal Single Use Biopsy Valve is intended to provide access for endoscopic device passage and exchange, help maintain insufflation, minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182275 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182275: Seal Single Use Biopsy Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182275
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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