510(k) · Cleared
ClearedSingle Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Cleared on May 27, 2025 as substantially equivalent to K171989 (Wilson-Cook Medical, Inc., 2018) after a 90-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- May 27, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- ODD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K851964 (1985). No later device cites it as a predicate yet.
- Root · 2 generations backK851964 E.R.C.P.-1 Endoscopic Retrograde Cholangio-CatheteWilson-Cook Medical, Inc. · 1985
- 1 generation backK171989 Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and…Wilson-Cook Medical, Inc. · 2018
- This deviceK250573 Single Use Cannula V…Olympus Medical Systems Corp. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K851964 | E.R.C.P.-1 Endoscopic Retrograde Cholangio-Cathete | Wilson-Cook Medical, Inc. | 1985 | — |
| −1 | K171989 | Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon… | Wilson-Cook Medical, Inc. | 2018 | — |
| 0 (this device) | K250573 | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q… | Olympus Medical Systems Corp. | 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 ODD? 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 ODD device
- #1 K202583 BioShield biopsy valve EUS - Linearscore 3.3 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K171989 | Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled…Summary page 5…Class II III. Predicate Device Substantial equivalence is claimed to the following device: • ERCP Catheters (ERCP, GT, FD-GT, HRC, and SUC), K171989, Wilson-Cook Medical Inc. IV. Device Description The Single Use Cannula V and the Single Use 2-Lumen Cannula… | 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 40 years and passes through 2 companies; a new generation was cleared every 32.8 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All ODD devicesODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · ODD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODD
Too few ODD 510(k)s in any year since 2007 to give a median.
Recalls per year · ODD
No recall names ODD since 2007.
Adverse event reports per year · ODD
4in 2025
MAUDE reports naming product code ODD, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 0 | — | 0 | 26 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 13 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q are intended to be used to inject contrast medium in the biliary or pancreatic duct in combination with an endoscope.
The Single Use 2-Lumen Cannula V PR-V614M is intended to be used to inject contrast medium in the biliary or pancreatic duct in combination with an endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250573: Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250573
Report an extraction error
Are you the manufacturer?
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