510(k) · Cleared
ClearedNovaGold High Performance Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neometrics, Inc. · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on Mar 16, 2015 as substantially equivalent to K133076 (Neometrics, Inc., 2014) after a 42-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Mar 16, 2015
- Review
- 42 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K910497 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK910497 Wilson Cook Wire Guide and Protective GuideWilson-Cook Medical, Inc. · 1991
- 3 generations backK033754 Tracer Metro Smart Wire GuideWilson-Cook Medical, Inc. · 2003
- 2 generations backK122816 Axcess Soft Tip Wire GuideWilson-Cook Medical, Inc. · 2012
- 1 generation backK133076 Novagold High Performance GuidewireNeometrics, Inc. · 2014 · Recalled
- This deviceK150225 NovaGold High Performance GuidewireNeometrics, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910497 | Wilson Cook Wire Guide and Protective Guide | Wilson-Cook Medical, Inc. | 1991 | — |
| −3 | K033754 | Tracer Metro Smart Wire Guide | Wilson-Cook Medical, Inc. | 2003 | — |
| −2 | K122816 | Axcess Soft Tip Wire Guide | Wilson-Cook Medical, Inc. | 2012 | — |
| −1 | K133076 | Novagold High Performance Guidewire | Neometrics, Inc. | 2014 | 1 |
| 0 (this device) | K150225 | NovaGold High Performance Guidewire | Neometrics, Inc. | 2015 | — |
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 |
|---|---|---|---|
| * | K133076 | Novagold High Performance GuidewireSummary page 4…h, MN 55447 January 30, 2015 NovaGold™ High Performance Guidewire Class II Regulation Number: 21 CFR 876.1500. OoCY The subject device is substantially equivalent to K133076; NovaGold High Perfomance Guidewire manufactured by NeoMetrics, Inc. The NovaGold Guidewire is constructed from a steerable, met… | 2014 |
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 2 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 4 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. 2015, 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 NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
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/K150225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150225: NovaGold High Performance Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150225
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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