510(k) · Cleared
ClearedCarotid Access Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · DYB Introducer, Catheter
Cleared on Jun 29, 2006 as substantially equivalent to K863138 (Terumo Medical Corp., 1986) and 2 other predicates after a 107-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Jun 29, 2006
- Review
- 107 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K924607 (1993). 4 ancestors in all, the oldest K863138 (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 | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro Set | Arrow Intl., Inc. | 1993 | 3 |
| −1 | K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | 2001 | 1 |
| 0 (this device) | K060666 | Carotid Access Kit | Terumo Medical Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 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 DYB? 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K863138 | Terumo Radifocus Guide WireSummary page 1…Guide Wire, Catheter, and Introducer B. PREDICATE DEVICE The predicate device are: Product Name: Terumo Radifocus® Guide Wire 510k #: K863138 Manufacaturer: Terumo Corporation Product Name: Terumo Angiographic Catheter 510k #: K915414 Manufacatur… | 1986 |
| * | K915414 | Terumo Angiogtaphic CatheterSummary page 1…Product Name: Terumo Radifocus® Guide Wire 510k #: K863138 Manufacaturer: Terumo Corporation Product Name: Terumo Angiographic Catheter 510k #: K915414 Manufacaturer: Terumo Corporation Product Name: Pinnacle Destination Carotid Guiding Sheath 510k #: K012812… | 1992 |
| * | K012812 | Carotid Guiding SheathSummary page 1…rumo Angiographic Catheter 510k #: K915414 Manufacaturer: Terumo Corporation Product Name: Pinnacle Destination Carotid Guiding Sheath 510k #: K012812 Manufacaturer: Terumo Medical Corporation C. INDICATIONS FOR USE The Glidewire® guide wire is designed to dire… | 2001 |
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 13 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 11 other devices also cite its predicate K863138.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
The Glidewire® guide wire is designed to direct a catheter to the desired anatomical location, including but not limited to the carotid arteries, during diagnostic or interventional procedures.
The GlideCath ® XP catheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system, including but not limited to the carotid arteries.
The Destination® Carotid Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the carotid arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060666: Carotid Access Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060666
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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