510(k) Report

510(k) · Cleared

Cleared

SureAx-Guide™

K250203510(k) TraditionalCleared Oct 17, 2025266-day reviewClass II21 CFR 870.1330

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sureax Medical, LLC · DQX Wire, Guide, Catheter

Cleared on Oct 17, 2025 as substantially equivalent to K091385 (Cook, Inc., 2009) after a 266-day review. Its family tree reaches back 1 generation to 2009.

Decided
Oct 17, 2025
Review
266 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K091385 (2009). No later device cites it as a predicate yet.

K091385 · Approach Hydro ST Wire Guide, Model HMW · Cook, Inc. · 2009 · recalled20052010201520202025
K091385 · Approach Hydro ST Wire Guide, Model HMW · Cook, Inc. · 2009 · recalled0
  1. Root · 1 generation backK091385 Approach Hydro ST Wire Guide, Model HMWCook, Inc. · 2009 · Recalled
  2. This deviceK250203 SureAx-Guide™Sureax Medical, LLC · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K091385Approach Hydro ST Wire Guide, Model HMWCook, Inc.20091
0 (this device)K250203SureAx-Guide™Sureax Medical, LLC2025—
FIG. 1 — Lineage of K250203, 2009–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DQX? 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 DQX device

  1. #1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K091385Approach Hydro ST Wire Guide, Model HMW
Summary page 5
…Class II Product Code and Regulation: DQX, 21 CFR 870.1330 III. PREDICATE DEVICE Primary Predicate COOK Inc- Approach Hydro ST Guidewire (K091385) IV. DEVICE DESCRIPTION The SureAx-Guide™ guidewire is comprised of a stainless-steel wire with a PTFE coating and di…
Cook, Inc.20091

Also cleared against K091385: 1 other device →

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?

  • Its one ancestor has a recall.
  • 1 other device also cites its predicate K091385.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · DQX

10in 2025

2007: 142008: 192009: 182010: 212011: 182012: 202013: 182014: 182015: 152016: 142017: 192018: 192019: 132020: 142021: 62022: 152023: 102024: 112025: 102026 (partial year): 12
2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007: 85 days median2008: 87 days median2009: 87 days median2010: 63 days median2011: 43 days median2012: 62 days median2013: 119 days median2014: 103 days median2015: 112 days median2016: 179 days median2017: 85 days median2018: 114 days median2019: 173 days median2020: 106 days median2021: 161 days median2022: 212 days median2023: 136 days median2024: 134 days median2025: 177 days median2026 (partial year): 145 days median
2007high 212 (2022) · low 43 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQX

3in 2024

2007: 122008: 72009: 492010: 342011: 32012: 52013: 7, 4 Class I2015: 12016: 2, 2 Class I2017: 172018: 92019: 22020: 1, 1 Class I2024: 32026 (partial year): 4, 1 Class I
2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007: 7602008: 7152009: 6872010: 9872011: 1,3112012: 1,3372013: 1,4742014: 1,3232015: 1,3232016: 1,4662017: 1,5242018: 1,7372019: 1,6792020: 1,5362021: 1,7132022: 1,6472023: 2,0682024: 2,2102025: 2,178
2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007148512760
200819877715
2009188749687
2010216334987
2011184331,311
2012206251,337
2013181197 (4)1,474
20141810301,323
20151511211,323
2016141792 (2)1,466
20171985171,524
20181911491,737
20191317321,679
2020141061 (1)1,536
2021616101,713
20221521201,647
20231013602,068
20241113432,210
20251017702,178
2026121454 (1)—

What is it indicated for?

The SureAx-Guide guidewire is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature. The SureAx-Guide guidewire is not intended for use in the coronary or neuro vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K091385

1 other device cites the same predicate.

  • K110009Roadrunner Uniglide Hydrophilic Wire GuideCook, Inc. · 20111 Class I recall

Recent decisions in DQX

The DQX category page

  • K260168Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)Skycade Med Corporation · 2026
  • K253146Hyperdrive 35 GuidewireRapid-Medical, Ltd. · 2026
  • K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd. · 2026
  • K253667Accoat Guide WireSp Medical A/S · 2026
  • K261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland, Ltd. · 2026

https://510kreport.com/device/K250203 · printed Nov 4, 2026

Cite this page

510(k) Report. “K250203: SureAx-Guide™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250203

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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