510(k) · Cleared
ClearedY WIRE 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safewire, LLC · HXI Passer, Wire, Orthopedic
Cleared on May 20, 2014 after a 75-day review. The FDA summary names its predicate without a number.
- Decided
- May 20, 2014
- Review
- 75 days
- Class
- Class I
- Product code
- HXI
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 HXI? 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? (2)
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 |
|---|---|---|---|
| * | — | K2M - K Wire Named without a submission number | |
| * | — | Nuvasive - K Wire 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.
How does its category compare?
All HXI devicesHXI Passer, Wire, Orthopedic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HXI
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · HXI
Too few HXI 510(k)s in any year since 2007 to give a median.
Recalls per year · HXI
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HXI
3in 2025
MAUDE reports naming product code HXI, 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 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 12 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 2 | 10 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 1 | 7 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Y-Wire2 guidewire is intended for use by surgeons to assist with the proper introduction and placement of orthopedic instruments and implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140576 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140576: Y WIRE 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140576
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026