510(k) · Cleared
Recalled · 2010Destination Carotid Guiding Sheath
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 Sep 6, 2005 as substantially equivalent to K012812 (Terumo Medical Corp., 2001) after a 26-day review. Its family tree reaches back 2 generations to 1993. 7 later devices descend from it. It has been recalled once.
- Decided
- Sep 6, 2005
- Review
- 26 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924607 (1993). 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 1 generation backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- This deviceK052185 Destination Carotid Guiding SheathTerumo Medical Corp. · 2005
- Descendant · cites it directly · 3 of its ownK171491 R2P Destination Slender Guiding SheathTerumo Medical Corporation · 2017
- Descendant · 2 generations on · 1 of its ownK193125 R2P Destination Slender Guiding SheathTerumo Medical Corporation · 2020
- Descendant · cites it directly · 1 of its ownK070166 Strada Carotid Guiding SheathSt Jude Medical · 2007
- Descendant · 3 generations on · 0 of its ownK261242 SimplGuidePendracare · 2026
- Descendant · 2 generations on · 0 of its ownK202167 Brite Tip Radianz Guiding SheathCordis Corporation · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K171491R2P Destination Slender Guiding SheathTerumo Medical Corporation · 2017 · cites it directly3descendants
- K193125R2P Destination Slender Guiding SheathTerumo Medical Corporation · 2020 · 2 generations on1descendant
- K070166Strada Carotid Guiding SheathSt Jude Medical · 2007 · cites it directly1descendant
- K261242SimplGuidePendracare · 2026 · 3 generations on0descendants
- K202167Brite Tip Radianz Guiding SheathCordis Corporation · 2021 · 2 generations on0descendants
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) | K052185 | Destination Carotid Guiding Sheath | Terumo Medical Corp. | 2005 | — |
| +1 | K171491 | R2P Destination Slender Guiding Sheath | Terumo Medical Corporation | 2017 | — |
| +2 | K193125 | R2P Destination Slender Guiding Sheath | Terumo Medical Corporation | 2020 | — |
| +1 | K070166 | Strada Carotid Guiding Sheath | St Jude Medical | 2007 | — |
| +3 | K261242 | SimplGuide | Pendracare | 2026 | — |
| +2 | K202167 | Brite Tip Radianz Guiding Sheath | Cordis Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K012812 | Carotid Guiding SheathSummary page 1…ces into the human vasculature, including but not limited to the carotid arteries. Note: This is the same intended use as the Carotid Guiding Sheath, K012812. D. DESCRIPTION The Destination "' Carotid Guiding Sheath is designed to perform as a guiding catheter and… | 2001 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2010 | Not classified | Z-2416-2011 | Equipment maintenance | Molding defect in destination product that render the device unusable. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K171491 (Terumo Medical Corporation, 2017) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K012812.
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 Destination ® Carotid Guiding Sheath is designed to be used 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/K052185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052185: Destination Carotid Guiding Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052185
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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