510(k) · Cleared
ClearedPinnacle Destination Peripheral 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 Aug 4, 2005 as substantially equivalent to K012812 (Terumo Medical Corp., 2001) after a 49-day review. Its family tree reaches back 2 generations to 1993. 2 of the 63 devices in its family, counting itself, have a Class I recall. 60 later devices descend from it.
- Decided
- Aug 4, 2005
- Review
- 49 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924607 (1993). 60 later devices descend from it, 4 citing it directly. 2 of the 63 devices in this family, counting this one, have a Class I recall.
- 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 deviceK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
- Descendant · cites it directly · 44 of its ownK080415 Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2008
- Descendant · cites it directly · 30 of its ownK091329 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2009 · Recalled
- Descendant · 2 generations on · 13 of its ownK142829 Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor…Cook Incorporated · 2015 · Recalled (Class I)
- Descendant · cites it directly · 13 of its ownK081341 Reinforced Catheter Introducer System (Rcis)Thomas Medical Products, Inc. · 2008
- Descendant · 2 generations on · 10 of its ownK111004 Hansen Medical Vascular Catheter Control System and CatheterHansen Medical, Inc. · 2012 · Recalled
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 60 · See all- K080415Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2008 · cites it directly44descendants
- K091329Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2009 · cites it directly30descendants
- K142829Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer…Cook Incorporated · 2015 · 2 generations on13descendants
- K081341Reinforced Catheter Introducer System (Rcis)Thomas Medical Products, Inc. · 2008 · cites it directly13descendants
- K111004Hansen Medical Vascular Catheter Control System and CatheterHansen Medical, Inc. · 2012 · 2 generations on10descendants
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) | K051601 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2005 | — |
| +1 | K080415 | Device Modification to Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2008 | — |
| +1 | K091329 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2009 | 1 |
| +2 | K142829 | Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo… | Cook Incorporated | 2015 | Class I |
| +1 | K081341 | Reinforced Catheter Introducer System (Rcis) | Thomas Medical Products, Inc. | 2008 | — |
| +2 | K111004 | Hansen Medical Vascular Catheter Control System and Catheter | Hansen Medical, Inc. | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 8 | 2 |
| 2016 | 6 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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.
2 devices in this family have a Class I recall. 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 2…id Guiding Sheath, which is manufactured by Terumo Medical Corporation. The Carotid Guiding Sheath is cleared through the premarket notification process (K012812). C. INTENDED USE The Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the intr… | 2001 |
What descends from it? (60)
See all 604 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K150186Chariot Guiding SheathBoston Scientific Corp · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K142829Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification…Cook Incorporated · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 121 Class I recalls
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, K080415 (Terumo Medical Corp., 2008) has gone furthest, with 44 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 Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the
introduction of interventional and diagnostic devices into the human vasculature,
including but not limited to lower extremity access via a contralateral approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051601 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051601: Pinnacle Destination Peripheral Guiding Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051601
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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