510(k) · Cleared
ClearedAxcess Soft Tip 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 Oct 9, 2012 as substantially equivalent to K033754 (Wilson-Cook Medical, Inc., 2003) after a 25-day review. Its family tree reaches back 2 generations to 1991. 3 later devices descend from it.
- Decided
- Oct 9, 2012
- Review
- 25 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910497 (1991). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK910497 Wilson Cook Wire Guide and Protective GuideWilson-Cook Medical, Inc. · 1991
- 1 generation backK033754 Tracer Metro Smart Wire GuideWilson-Cook Medical, Inc. · 2003
- This deviceK122816 Axcess Soft Tip Wire GuideWilson-Cook Medical, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK133076 Novagold High Performance GuidewireNeometrics, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK150225 NovaGold High Performance GuidewireNeometrics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK142950 Acrobat Calibrated Tip Wire GuideWilson-Cook Medical, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910497 | Wilson Cook Wire Guide and Protective Guide | Wilson-Cook Medical, Inc. | 1991 | — |
| −1 | K033754 | Tracer Metro Smart Wire Guide | Wilson-Cook Medical, Inc. | 2003 | — |
| 0 (this device) | K122816 | Axcess Soft Tip Wire Guide | Wilson-Cook Medical, Inc. | 2012 | — |
| +1 | K133076 | Novagold High Performance Guidewire | Neometrics, Inc. | 2014 | 1 |
| +2 | K150225 | NovaGold High Performance Guidewire | Neometrics, Inc. | 2015 | — |
| +1 | K142950 | Acrobat Calibrated Tip Wire Guide | Wilson-Cook Medical, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K033754 | Tracer Metro Smart Wire GuideSummary page 1…Predicate Device: Wilson-Cook Tracer Metro Smart Wire Guide (k033754) Intended Use: Intended to assist in cannulation of the biliary… | 2003 |
What descends from it? (3)
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?
- The line of descent spans 21 years and passes through 1 company; a new generation was cleared every 12.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K133076 (Neometrics, Inc., 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OCY devicesOCY Endoscopic Guidewire, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
This device is intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122816: Axcess Soft Tip 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/K122816
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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