510(k) · Cleared
ClearedHYBRID Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Balt USA, LLC · MOF Guide, Wire, Catheter, Neurovasculature
Cleared on Oct 4, 2018 as substantially equivalent to K133725 (MicroVention, Inc., 2014) after a 37-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Oct 4, 2018
- Review
- 37 days
- Class
- Class II
- Product code
- MOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953533 (1995). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK953533 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1995
- 4 generations backK961445 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1996
- 3 generations backK063695 Runthrough NSTerumo Medical Corp. · 2007 · Recalled
- 2 generations backK080863 Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc. · 2008
- 1 generation backK133725 Traxcess 14 GuidewireMicroVention, Inc. · 2014
- This deviceK182337 HYBRID GuidewireBalt USA, LLC · 2018
- Descendant · cites it directly · 0 of its ownK252011 CHIKAI Nexus petitAsahi Intecc Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252011CHIKAI Nexus petitAsahi Intecc Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953533 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1995 | — |
| −4 | K961445 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1996 | — |
| −3 | K063695 | Runthrough NS | Terumo Medical Corp. | 2007 | 1 |
| −2 | K080863 | Traxcess 0.014 Hydrophilic Guidewire | MicroVention, Inc. | 2008 | — |
| −1 | K133725 | Traxcess 14 Guidewire | MicroVention, Inc. | 2014 | — |
| 0 (this device) | K182337 | HYBRID Guidewire | Balt USA, LLC | 2018 | — |
| +1 | K252011 | CHIKAI Nexus petit | Asahi Intecc Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 MOF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MOF device
- #1 K253168 0.014” Willow Guidewirescore 17.9 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K133725 | Traxcess 14 GuidewireSummary page 4…ion of Neurological and Physical Medicine Devices (Office of Device Evaluation, CDRH) PREDICATE DEVICE [807.92(a)(3)] Traxcess 14 Guidewire (K133725) REFERENCE DEVICES Traxcess 0.007” Mini Guidewire (K161803) Transend 300 ES Guidewire and Transend 300 Floppy Guidewire (K02235… | 2014 |
| † | K161803 | Traxcess .007 Mini Guidewire | 2016 |
| † | K022357 | Transend 300 ES Guidewire, Model 46-814 & Transend 300 Floppy Guidewire, Model 46-815 | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252011 | CHIKAI Nexus petit | 2026 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K252011 (Asahi Intecc Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K133725.
How does its category compare?
All MOF devicesMOF Guide, Wire, Catheter, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MOF
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MOF
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOF
No recall names MOF since 2007.
Adverse event reports per year · MOF
135in 2025
MAUDE reports naming product code MOF, 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 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 133 | 0 | 5 |
| 2016 | 4 | 61 | 0 | 3 |
| 2017 | 1 | — | 0 | 15 |
| 2018 | 2 | — | 0 | 11 |
| 2019 | 4 | 58 | 0 | 12 |
| 2020 | 4 | 36 | 0 | 18 |
| 2021 | 0 | — | 0 | 39 |
| 2022 | 1 | — | 0 | 92 |
| 2023 | 4 | 199 | 0 | 91 |
| 2024 | 2 | — | 0 | 95 |
| 2025 | 5 | 172 | 0 | 135 |
| 2026 | 11 | 192 | 0 | — |
What is it indicated for?
The HYBRID Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in the coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182337: HYBRID Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182337
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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