510(k) · Cleared
ClearedNipro Hydrophilic Guidewire for Urological & Laparoscopic Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corporation · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on Feb 28, 2006 as substantially equivalent to K001251 (Nipro Medical Corp., 2000) and 2 other predicates after a 54-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Feb 28, 2006
- Review
- 54 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K923607 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK923607 Radifocus Guide Wire MTerumo Medical Corp. · 1992
- This deviceK060034 Nipro Hydrophilic Guidewire for Urological & Laparoscopic UseNipro Medical Corporation · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923607 | Radifocus Guide Wire M | Terumo Medical Corp. | 1992 | — |
| 0 (this device) | K060034 | Nipro Hydrophilic Guidewire for Urological & Laparoscopic Use | Nipro Medical Corporation | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K001251 | Sniper, Model or-3872XX SeriesSummary page 1…endoscopic accessories. 807.92 (a)(6) Comparison of Technical Characteristics: The Nipro subject device is either identical (K001251) or very similar to the predicate devices materials. design and technological characteristics,… | 2000 |
| * | K926214 | Guide Wire for Laporoscopic UseSummary page 1…ubstantially Equivalent Device: Nipro Hydrophilic Guidewire (KO01251) Terumo Medical Corporation RadiFocus Guidewire (K926214, K923607) 807.92 (a)(4) Description of Device: The subject devices is contructed from a… | 1993 |
| * | K923607 | Radifocus Guide Wire MSummary page 1…lly Equivalent Device: Nipro Hydrophilic Guidewire (KO01251) Terumo Medical Corporation RadiFocus Guidewire (K926214, K923607) 807.92 (a)(4) Description of Device: The subject devices is contructed from a superelas… | 1992 |
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?
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All OCY devicesOCY Endoscopic Guidewire, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Nipro Hydrophilic Guidewires are designed for use in urological, laparoscopic, and radiological procedmes where a smooth guidewire is desired to introduce/position catheters, direct and maintain access, and be used to guide and exchange endoscopic accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060034 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060034: Nipro Hydrophilic Guidewire for Urological & Laparoscopic Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060034
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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