510(k) · Cleared
ClearedKayak Hydrophilic Guide Wires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DOX Fluorometer, Lead (Dedicated Instruments)
Cleared on Mar 19, 2002 as substantially equivalent to K961445 (Terumo Medical Corp., 1996) and 1 other predicate after an 88-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Mar 19, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- DOX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K953533 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK953533 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1995
- 1 generation backK961445 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1996
- This deviceK014195 Kayak Hydrophilic Guide WiresBoston Scientific Corp · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953533 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1995 | — |
| −1 | K961445 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1996 | — |
| 0 (this device) | K014195 | Kayak Hydrophilic Guide Wires | Boston Scientific Corp | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 DOX? 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 |
|---|---|---|---|
| * | K961445 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilSummary page 1…™ Guide Wires Classification Name Catheter Guide Wire The following predicate devices are currently marketed. Product 510(k) Clearance Date Terumo Radifocus Glidewire K961445 07/09/1996 Cordis Hydronol Steerable K973845 01/05/1998 Guidewire 6-1 510(k) Notification SCIMED Guide Wires S… | 1996 |
| * | K973845 | Cordis Hydronol Steerable GuidewireSummary page 1…uide Wire The following predicate devices are currently marketed. Product 510(k) Clearance Date Terumo Radifocus Glidewire K961445 07/09/1996 Cordis Hydronol Steerable K973845 01/05/1998 Guidewire 6-1 510(k) Notification SCIMED Guide Wires Summary of Safety and Effectiveness, Continued… | 1998 |
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 7 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K961445.
How does its category compare?
All DOX devicesDOX Fluorometer, Lead (Dedicated Instruments): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DOX
FDA has decided no DOX device since 2007.
Median 510(k) review, days · DOX
Too few DOX 510(k)s in any year since 2007 to give a median.
Recalls per year · DOX
No recall names DOX since 2007.
Adverse event reports per year · DOX
2in 2014
MAUDE reports naming product code DOX, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Boston Scientific Corporation (BSC) Kayak™ Hydrophilic Guide Wires are intended to facilitate the placement of a catheter during diagnostic or interventional procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. This device is not intended for use in the coronary arteries or the neurovasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014195: Kayak Hydrophilic Guide Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014195
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026