510(k) · Cleared
ClearedOstavi Hydrophilic Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lake Region Medical · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on Feb 26, 2013 as substantially equivalent to K081708 (Lake Region Mfg., Inc., 2008) and 1 other predicate after a 57-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Feb 26, 2013
- Review
- 57 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K922302 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922302 | Jagwire (TM) Recanalization Guidewire | Boston Scientific Corp | 1992 | — |
| −1 | K081708 | Taxi Endoscopic Guidewire | Lake Region Mfg., Inc. | 2008 | — |
| 0 (this device) | K124052 | Ostavi Hydrophilic Guidewire | Lake Region Medical | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (2)
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 1…nterology/Urology (OCY). This type of Guidewire was originally listed as a Class 11device by the Gastroenterology/Urology (OCY) review panel. IDNIIAIWF06f K081708F Lake Region Medical ' Taxi Endoscopic Guidewire K(000011 Lake Region Medical… | 2008 |
| * | K000011 | Modified Hydrophilic Coated GuidewireSummary page 2…708. The NaviProTM Guidewire is the exact same design as the ZlPwire, with a different intended use, legally marketed by Lake Region Medical and cleared by 510(k) K000011. The NaviProTM Guidewire has the exact same physical characteristics as the secondary predicate device (ZlPwire). The safe… | 2000 |
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 21 years and passes through 3 companies; a new generation was cleared every 16.1 years on median.
- None of the 3 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. 2013, 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 endloscopic guidewire is intended for use in selective cannulation of the blilary ducts including, but not limited to the common bile, pancreatic, cystic, right and left hepatic ducts. The endloscopic guidewire is designed to be used during endloscopic pancreatic-biliary procedures for catheter Introduction and exchanges of catheters, cannulas and sphicterotornes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K124052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124052: Ostavi Hydrophilic Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124052
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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