510(k) · Cleared

Recalled · Class II · 2013

Pinnacle Destination Peripheral Guiding Sheath

K091329510(k) SpecialCleared May 29, 200924-day reviewClass II21 CFR 870.1340Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Terumo Medical Corp. · DYB Introducer, Catheter

Cleared on May 29, 2009 as substantially equivalent to K051601 (Terumo Medical Corp., 2005) and 1 other predicate after a 24-day review. Its family tree reaches back 4 generations to 1993. 2 of the 35 devices in its family, counting itself, have a Class I recall. 30 later devices descend from it. It has been recalled once.

Decided: May 29, 2009
Review: 24 days
Class: Class II
Product code: DYB
Recalls: 1
Predicates: 2

Its longest line of descent runs back 4 generations to K924607 (1993). 30 later devices descend from it, 8 citing it directly. 2 of the 35 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
3 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
2 generations backK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
1 generation backK080415 Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2008
This deviceK091329 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2009
Descendant · cites it directly · 13 of its ownK142829 Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor…Cook Incorporated · 2015 · Recalled (Class I)
Descendant · cites it directly · 10 of its ownK100799 Fortress Introducer Sheath System Model 358813, 358814, 358815Contract Medical Intl. GmbH · 2011
Descendant · 2 generations on · 6 of its ownK152913 GORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleCreganna Medical Aslo Business AS Cregganna Tactx Medical · 2016 · Recalled
Descendant · cites it directly · 6 of its ownK142357 DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2015
Descendant · cites it directly · 5 of its ownK181463 DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2018

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2010high 5 (2015) · low 0 (2012)2026

Class I recalls in this family

K150186 Chariot Guiding Sheathcites it directly · 2015
K142829 Flexor Tuohy-Borst Side-Arm Introducer, Ansel…cites it directly · 2015

Most influential descendants

Showing 5 of 30 · See all

K142829Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer…Cook Incorporated · 2015 · cites it directly13descendants
K100799Fortress Introducer Sheath System Model 358813, 358814, 358815Contract Medical Intl. GmbH · 2011 · cites it directly10descendants
K152913GORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleCreganna Medical Aslo Business AS Cregganna Tactx Medical · 2016 · 2 generations on6descendants
K142357DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2015 · cites it directly6descendants
K181463DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2018 · cites it directly5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K924607	Arrow Fischell Kink Resist Percut Sheath Intro Set	Arrow Intl., Inc.	1993	3
−3	K012812	Carotid Guiding Sheath	Terumo Medical Corp.	2001	1
−2	K051601	Pinnacle Destination Peripheral Guiding Sheath	Terumo Medical Corp.	2005	—
−1	K080415	Device Modification to Pinnacle Destination Peripheral Guiding Sheath	Terumo Medical Corp.	2008	—
0 (this device)	K091329	Pinnacle Destination Peripheral Guiding Sheath	Terumo Medical Corp.	2009	—
+1	K142829	Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo…	Cook Incorporated	2015	Class I
+1	K100799	Fortress Introducer Sheath System Model 358813, 358814, 358815	Contract Medical Intl. GmbH	2011	—
+2	K152913	GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle	Creganna Medical Aslo Business AS Cregganna Tactx Medical	2016	1
+1	K142357	DuraSheath Introducer Sheath System	Contract Medical International, GmbH	2015	—
+1	K181463	DuraSheath Introducer Sheath System	Contract Medical International, GmbH	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	1	0
2015	5	2
2016	4	0
2017	2	0
2018	2	0
2020	3	0
2021	4	0
2022	2	0
2023	2	0
2024	1	0
2025	3	0

FIG. 1 — Lineage of K091329, 1993–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K051601	Pinnacle Destination Peripheral Guiding Sheath Summary page 3 …valent in intended use, design, principle of operation / technology, materials and performance to the Pinnacle® Destination® Peripheral Guiding Sheath (K05 1601 and K0804 15), which is manufactured by Terumo Medical Corporation. Differences between the devices do not raise any iss…	Terumo Medical Corp.	2005	—
*	K080415	Device Modification to Pinnacle Destination Peripheral Guiding Sheath Summary page 1 …by Terumo Medical Corporation. The Pinnacle® Destination® Peripheral Guiding Sheath is cleared through the premarket notification process (KO51601 and K080415). C. INTENDED USE The Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the i…	Terumo Medical Corp.	2008	—

Also cleared against K051601: 3 other devices →

What descends from it? (30)

See all 30

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K142829	Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer… Class I	Cook Incorporated	2015	13
K100799	Fortress Introducer Sheath System Model 358813, 358814, 358815	Contract Medical Intl. GmbH	2011	10
K142357	DuraSheath Introducer Sheath System	Contract Medical International, GmbH	2015	6
K181463	DuraSheath Introducer Sheath System	Contract Medical International, GmbH	2018	5
K142819	Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set	Cook Incorporated	2015	1
K172995	Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination…	Terumo Medical Corporation	2017	0
K150186	Chariot Guiding Sheath Class I	Boston Scientific Corp	2015	0
K101625	Cohen Crossover Catheter	Vascular Solutions, Inc.	2010	0

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 30, 2013	Class II	Z-1611-2013	Error in labeling	Medical devices were incorrectly labeled with extended expiration dates.

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 · Cites it directly · ◆ 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 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 121 Class I recalls

What does this lineage say?

The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
2 of the 4 ancestors have a recall of any class.
Of its descendants, K142829 (Cook Incorporated, 2015) has gone furthest, with 13 descendants of its own.
3 other devices also cite its predicate K051601.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · DYB

16in 2025

2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007high 156 (2018) · low 37 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DYB

3in 2025

2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007high 4,539 (2025) · low 316 (2007)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/K091329 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091329: Pinnacle Destination Peripheral 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/K091329

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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