510(k) · Cleared
ClearedXENX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xenolith Medical · OCY Endoscopic Guidewire, Gastroenterology-Urology
Cleared on Aug 9, 2012 as substantially equivalent to K082536 (Cook Urological, Inc., 2008) and 3 other predicates after a 238-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Aug 9, 2012
- Review
- 238 days
- Class
- Class II
- Product code
- OCY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K871777 (1987). 8 ancestors in all, the oldest K863081 (1986). 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 | K871777 | Van-Tec Reusable Helical Stone Basket | Van-Tec, Inc. | 1987 | — |
| −1 | K970121 | Stone Dislodger, Basket | Boston Scientific Corp | 1997 | — |
| 0 (this device) | K113692 | XENX | Xenolith Medical | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 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? (5)
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 |
|---|---|---|---|
| * | K082536 | Cook Wire GuidesSummary page 2…for Submission: New device Predicate Devices: * Sensor Nitinol Guidewire, Boston Scientific Gorp, 5 10(k) Exempt * Roadrunner PC Wire Guide, Cook Urological Inc, K082536 * Stone Cone Nitinol Urological retrieval coil, Boston Scientific Corp, K970121 * Accordion urological occluding guid… | 2008 |
| * | K970121 | Stone Dislodger, BasketSummary page 2…entific Gorp, 5 10(k) Exempt * Roadrunner PC Wire Guide, Cook Urological Inc, K082536 * Stone Cone Nitinol Urological retrieval coil, Boston Scientific Corp, K970121 * Accordion urological occluding guidewire, Peresys, K052048 * NTrap stone entrapment and extraction device, Cook Urologica… | 1997 |
| * | K052048 | AccordionSummary page 2…Urological Inc, K082536 * Stone Cone Nitinol Urological retrieval coil, Boston Scientific Corp, K970121 * Accordion urological occluding guidewire, Peresys, K052048 * NTrap stone entrapment and extraction device, Cook Urological Inc, K863081 Device Description: The XenX device combi… | 2005 |
| * | K863081 | 4-Wire (Carson) Stone ExtractorSummary page 2…entific Corp, K970121 * Accordion urological occluding guidewire, Peresys, K052048 * NTrap stone entrapment and extraction device, Cook Urological Inc, K863081 Device Description: The XenX device combines several features in one device which facilitate an endoscopic procedure. The XenX… | 1986 |
| * | — | Sensor Nitinol Guidewire Named without a submission number |
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 25 years and passes through 3 companies; a new generation was cleared every 15.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K082536.
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?
The XenX device is intended to be used endoscopically to bypass and entrap calculi from the urinary tract, to prevent retrograde migration of calculi during laser lithotripsy, and to facilitate the placement of endourological instruments during diagnostic or interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113692: XENX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113692
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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