510(k) · Cleared
ClearedEasyPass Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi-Globe Corporation · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on May 19, 2016 as substantially equivalent to K081708 (Lake Region Mfg., Inc., 2008) after a 189-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- May 19, 2016
- Review
- 189 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922302 (1992). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 OCY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K081708 | Taxi Endoscopic GuidewireSummary page 5…duct Code: OCY C. Predicate Device: Trade Name: Taxi Endoscopic Guidewire Manufacturer: Lake Region Manufacturing, Inc. Clearance Number: K081708 Common Name: Endoscopic Guidewire, Gastroenterology-Urology Classification Name: Endoscope and Accessories 21 C… | 2008 |
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 24 years and passes through 3 companies; a new generation was cleared every 16.1 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K081708.
How does its category compare?
All OCY devicesOCY Endoscopic Guidewire, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OCY
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · OCY
51in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCY
8in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCY
133in 2025
MAUDE reports naming product code OCY, 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 | 3 |
| 2008 | 3 | 55 | 0 | 7 |
| 2009 | 1 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 4 | 60 | 0 | 32 |
| 2014 | 5 | 41 | 0 | 51 |
| 2015 | 3 | 51 | 0 | 283 |
| 2016 | 1 | — | 0 | 158 |
| 2017 | 0 | — | 0 | 85 |
| 2018 | 0 | — | 0 | 101 |
| 2019 | 0 | — | 8 | 103 |
| 2020 | 0 | — | 0 | 128 |
| 2021 | 0 | — | 0 | 94 |
| 2022 | 0 | — | 0 | 134 |
| 2023 | 0 | — | 0 | 115 |
| 2024 | 0 | — | 0 | 131 |
| 2025 | 0 | — | 0 | 133 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EasyPass Guidewire is used for selective cannulation of the biliary ducts including, but not limited to the common bile duct, cystic duct, and right and left hepatic ducts. The EasyPass guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges.
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/K153264 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153264: EasyPass Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153264
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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