510(k) · Cleared
ClearedTaxi Endoscopic Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lake Region Mfg., Inc. · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on Aug 26, 2008 as substantially equivalent to K922302 (Boston Scientific Corp, 1992) after a 70-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.
- Decided
- Aug 26, 2008
- Review
- 70 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922302 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK922302 Jagwire (TM) Recanalization GuidewireBoston Scientific Corp · 1992
- This deviceK081708 Taxi Endoscopic GuidewireLake Region Mfg., Inc. · 2008
- Descendant · cites it directly · 0 of its ownK153264 EasyPass GuidewireMedi-Globe Corporation · 2016
- Descendant · cites it directly · 0 of its ownK124052 Ostavi Hydrophilic GuidewireLake Region Medical · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922302 | Jagwire (TM) Recanalization Guidewire | Boston Scientific Corp | 1992 | — |
| 0 (this device) | K081708 | Taxi Endoscopic Guidewire | Lake Region Mfg., Inc. | 2008 | — |
| +1 | K153264 | EasyPass Guidewire | Medi-Globe Corporation | 2016 | — |
| +1 | K124052 | Ostavi Hydrophilic Guidewire | Lake Region Medical | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 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 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 |
|---|---|---|---|
| * | K922302 | Jagwire (TM) Recanalization GuidewireSummary page 1…OCY, Endoscope and accessories (21 CER 876.1500). 5.6 PREDICATE DEVICE g - . ~~~~~~.- 111I47 4 T IK922302 Boston Scientific Corp. Jagwirelh Recanalization Guidewire 5.7 DEVICE DESCRIPTION The Taxi®… | 1992 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All OCY devicesOCY Endoscopic Guidewire, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Endoscopic Guidewire is intended for use in selective cannulation of the biliary ducts
including, but not limited to the common bile, cystic, right and left hepatic ducts. The Endoscopic Guidewire is designed to be used during endoscopic biliary procedures for catheter
introduction and exchanges of catheters, cannulas, and sphincterotomes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081708 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081708: Taxi Endoscopic Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081708
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