510(k) · Cleared
ClearedSingle-Use Biopsy Valve (MAJ-1555)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · OCX Endoscopic Irrigation/Suction System
Cleared on Sep 25, 2025 as substantially equivalent to K182275 (Boston Scientific Corporation, 2018) after a 90-day review. Its family tree reaches back 4 generations to 2011.
- Decided
- Sep 25, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K111821 (2011). No later device cites it as a predicate yet.
- Root · 4 generations backK111821 Biopsy ValveEndochoice, Inc. · 2011
- 3 generations backK133734 Seal Single-Use Biopsy ValveEndochoice, Inc. · 2014
- 2 generations backK161167 Seal Single-Use Biopsy ValveEndochoice, Inc. · 2016
- 1 generation backK182275 Seal Single Use Biopsy ValveBoston Scientific Corporation · 2018
- This deviceK251997 Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K111821 | Biopsy Valve | Endochoice, Inc. | 2011 | — |
| −3 | K133734 | Seal Single-Use Biopsy Valve | Endochoice, Inc. | 2014 | — |
| −2 | K161167 | Seal Single-Use Biopsy Valve | Endochoice, Inc. | 2016 | — |
| −1 | K182275 | Seal Single Use Biopsy Valve | Boston Scientific Corporation | 2018 | — |
| 0 (this device) | K251997 | Single-Use Biopsy Valve (MAJ-1555) | Olympus Medical Systems Corporation | 2025 | — |
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 |
|---|---|---|---|
| * | K182275 | Seal Single Use Biopsy ValveSummary page 6…Single Use Biopsy Valve MAJ-1555 3. PREDICATE DEVICE • Trade Name: Seal™ Single Use Biopsy Valve • Model: SBC-501 • 510(k) Number: K182275 4. DEVICE DESCRIPTION The Olympus Single Use Biopsy Valve MAJ-1555 is a sterile, disposable device designed to attach to t… | 2018 |
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 MAJ-1555 has been designed to be attached to the instrument channel port of the endoscopes and 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/K251997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251997: Single-Use Biopsy Valve (MAJ-1555).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251997
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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