510(k) · Decided
Recalled · Class II · 2026Orca Air/Water and Suction Valves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · ODC Endoscope Channel Accessory
Cleared on Oct 9, 2025 as substantially equivalent to K160403 (Endochoice, Inc., 2016) after a 27-day review. Its family tree reaches back 3 generations to 2000. It has been recalled once.
- Decided
- Oct 9, 2025
- Review
- 27 days
- Class
- Class II
- Product code
- ODC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001241 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK001241 Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/IThe Olympus Optical Co. · 2000 · Recalled
- 2 generations backK102409 Defendo Disposable Air/Water Valve Model 100304Byrne Medical, Inc. · 2010
- 1 generation backK160403 SmartStart Air/Water and Suction ValvesEndochoice, Inc. · 2016
- This deviceK252910 Orca Air/Water and Suction ValvesBoston Scientific · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001241 | Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I | The Olympus Optical Co. | 2000 | 1 |
| −2 | K102409 | Defendo Disposable Air/Water Valve Model 100304 | Byrne Medical, Inc. | 2010 | — |
| −1 | K160403 | SmartStart Air/Water and Suction Valves | Endochoice, Inc. | 2016 | — |
| 0 (this device) | K252910 | Orca Air/Water and Suction Valves | Boston Scientific | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 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 14.0 · 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 |
|---|---|---|---|
| * | K160403 | SmartStart Air/Water and Suction ValvesSummary page 5…1500 Product Code: ODC Classification: Class II III. Predicate Device Orca Air/Water and Suction Valves, K160403 This predicate has not been subject to a design-related recall. No reference devices were use… | 2016 |
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 |
|---|---|---|---|---|
| May 12, 2026 | Class II | Z-2413-2026 | Process control | Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 9.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
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 Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.
The Orca Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252910 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252910: Orca Air/Water and Suction Valves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252910
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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