510(k) · Cleared
ClearedDestination Renal 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 May 28, 2008 as substantially equivalent to K012854 (Terumo Medical Corp., 2001) after a 44-day review. Its family tree reaches back 2 generations to 1993. 5 later devices descend from it.
- Decided
- May 28, 2008
- Review
- 44 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924607 (1993). 5 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 backK012854 Renal Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- This deviceK081045 Destination Renal Guiding SheathTerumo Medical Corp. · 2008
- Descendant · cites it directly · 2 of its ownK122958 Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 1 of its ownK210627 Breezeway IIOscor, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK242756 Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075…Pulnovo Medical (Wuxi) Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK172995 Destination Carotid Guiding Sheath, Destination Peripheral Guiding…Terumo Medical Corporation · 2017
- Descendant · cites it directly · 0 of its ownK140641 Vessix Guide Sheath 7F, 45 CM, RDC, Vessix Guide Sheath 7F, 45CM, LimaBoston Scientific Corporation · 2014
Most influential descendants
Showing 5 of 5 · See all- K122958Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2012 · cites it directly2descendants
- K210627Breezeway IIOscor, Inc. · 2021 · 2 generations on1descendant
- K242756Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090…Pulnovo Medical (Wuxi) Co., Ltd. · 2024 · 3 generations on0descendants
- K172995Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination…Terumo Medical Corporation · 2017 · cites it directly0descendants
- K140641Vessix Guide Sheath 7F, 45 CM, RDC, Vessix Guide Sheath 7F, 45CM, LimaBoston Scientific Corporation · 2014 · cites it directly0descendants
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 | K012854 | Renal Guiding Sheath | Terumo Medical Corp. | 2001 | 2 |
| 0 (this device) | K081045 | Destination Renal Guiding Sheath | Terumo Medical Corp. | 2008 | — |
| +1 | K122958 | Delivery Sheath, Model Adelante Breezeway | Oscor, Inc. | 2012 | 30 |
| +2 | K210627 | Breezeway II | Oscor, Inc. | 2021 | — |
| +3 | K242756 | Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080… | Pulnovo Medical (Wuxi) Co., Ltd. | 2024 | — |
| +1 | K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath… | Terumo Medical Corporation | 2017 | — |
| +1 | K140641 | Vessix Guide Sheath 7F, 45 CM, RDC, Vessix Guide Sheath 7F, 45CM, Lima | Boston Scientific Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K012854 | Renal Guiding Sheath | 2001 |
What descends from it? (5)
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)
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 15 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, K122958 (Oscor, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K012854.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Renal Guiding Sheath is intended for the introduction of interventional
and diagnostic devices into the human vasculature including but not limited to the Renal
Arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081045 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081045: Destination Renal Guiding Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081045
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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