510(k) · Cleared
ClearedTracer Metro Smart Wire Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on Dec 30, 2003 as substantially equivalent to K910497 (Wilson-Cook Medical, Inc., 1991) after a 29-day review. Its family tree reaches back 1 generation to 1991. 4 later devices descend from it.
- Decided
- Dec 30, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910497 (1991). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK910497 Wilson Cook Wire Guide and Protective GuideWilson-Cook Medical, Inc. · 1991
- This deviceK033754 Tracer Metro Smart Wire GuideWilson-Cook Medical, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK122816 Axcess Soft Tip Wire GuideWilson-Cook Medical, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK133076 Novagold High Performance GuidewireNeometrics, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK150225 NovaGold High Performance GuidewireNeometrics, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK142950 Acrobat Calibrated Tip Wire GuideWilson-Cook Medical, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K122816Axcess Soft Tip Wire GuideWilson-Cook Medical, Inc. · 2012 · cites it directly3descendants
- K133076Novagold High Performance GuidewireNeometrics, Inc. · 2014 · 2 generations on1descendant
- K150225NovaGold High Performance GuidewireNeometrics, Inc. · 2015 · 3 generations on0descendants
- K142950Acrobat Calibrated Tip Wire GuideWilson-Cook Medical, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910497 | Wilson Cook Wire Guide and Protective Guide | Wilson-Cook Medical, Inc. | 1991 | — |
| 0 (this device) | K033754 | Tracer Metro Smart Wire Guide | Wilson-Cook Medical, Inc. | 2003 | — |
| +1 | K122816 | Axcess Soft Tip Wire Guide | Wilson-Cook Medical, Inc. | 2012 | — |
| +2 | K133076 | Novagold High Performance Guidewire | Neometrics, Inc. | 2014 | 1 |
| +3 | K150225 | NovaGold High Performance Guidewire | Neometrics, Inc. | 2015 | — |
| +2 | K142950 | Acrobat Calibrated Tip Wire Guide | Wilson-Cook Medical, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K910497 | Wilson Cook Wire Guide and Protective GuideSummary page 4…with a full range of Wilson-Cock accessories. We believe the proposed device to be substantially equivalent to currently marketed Wilson-Caok wire guides as cleared per k910497, We believe the proposed device to be substantially equivalent to the named predicate in terms of performance characteristics te… | 1991 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122816 | Axcess Soft Tip Wire Guide | 2012 | 3 |
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.
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 Tracer Metro Smart Wire Guide is intended to assist in cannulation of the billary and
pancreatic ducts and to aid in bridging difficult strictures during ERCP.
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/K033754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033754: Tracer Metro Smart Wire Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033754
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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