510(k) · Cleared
Recalled · Class II · 2026Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · ODC Endoscope Channel Accessory
Cleared on Jul 16, 2025 as substantially equivalent to K202104 (STERIS Corporation, 2021) after a 110-day review. Its family tree reaches back 2 generations to 2019. It has been recalled 2 times.
- Decided
- Jul 16, 2025
- Review
- 110 days
- Class
- Class II
- Product code
- ODC
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K192059 (2019). No later device cites it as a predicate yet.
- Root · 2 generations backK192059 Bio Guard Air/Water & Suction ValvesUnited States Endoscopy Group, Inc. · 2019
- 1 generation backK202104 BioGuard EUS Air/Water and Suction ValvesSTERIS Corporation · 2021
- This deviceK250949 Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K192059 | Bio Guard Air/Water & Suction Valves | United States Endoscopy Group, Inc. | 2019 | — |
| −1 | K202104 | BioGuard EUS Air/Water and Suction Valves | STERIS Corporation | 2021 | — |
| 0 (this device) | K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | 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 ODC? 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 ODC device
- #1 K232329 Defendo Fujifilm 700 Single Use Biopsy Valve…score 14.1 · 6 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 |
|---|---|---|---|
| * | K202104 | BioGuard EUS Air/Water and Suction ValvesSummary page 5…ODC (endoscope channel accessory) Device Panel: Gastroenterology & Urology 3. Predicate Device Information BioGuard EUS Air/Water and Suction Valves K202104 4. Device Description The Suction Valve MAJ-1443 and Air/Water Valve MAJ-1444 have been designed for use with an Olympus ultras… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 12, 2026 | Class II | Z-1610-2026 | Reprocessing Controls | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. |
| Feb 12, 2026 | Class II | Z-1611-2026 | Reprocessing Controls | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K202104.
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · ODC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODC
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODC
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODC
91in 2025
MAUDE reports naming product code ODC, 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 | 3 | 83 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 67 | 0 | 0 |
| 2011 | 4 | 143 | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 8 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 4 | 55 | 0 | 40 |
| 2020 | 4 | 128 | 0 | 54 |
| 2021 | 6 | 181 | 0 | 52 |
| 2022 | 8 | 118 | 0 | 37 |
| 2023 | 7 | 126 | 0 | 43 |
| 2024 | 8 | 95 | 0 | 100 |
| 2025 | 6 | 106 | 0 | 91 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The AIR/WATER VALVE MAJ-1444 and SUCTION VALVE MAJ-1443 have been designed for use with an Olympus ultrasound endoscope for the gastrointestinal (Gl) tract, as follows.
Air/Water Valve (MAJ-1444)
- To feed air to remove any fluids or debris adhering to the objective lens.
- To feed water for lens washing.
- To fill the balloon with sterile water.
Suction Valve (MAJ-1443)
- To remove any fluids, debris, or air from the patient.
- To remove the water from the balloon.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250949 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250949: Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250949
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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