510(k) · Cleared

Cleared

Modification to Pinnacle Roii Hiflow Introducer Sheath

K062446510(k) SpecialCleared Oct 23, 200662-day reviewClass II21 CFR 870.1340

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 Oct 23, 2006 as substantially equivalent to K003424 (Terumo Medical Corp., 2000) after a 62-day review. Its family tree reaches back 1 generation to 2000.

Decided: Oct 23, 2006
Review: 62 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003424 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK003424 Pinnacle R/O II or Radifocus Introducer IITerumo Medical Corp. · 2000
This deviceK062446 Modification to Pinnacle Roii Hiflow Introducer SheathTerumo Medical Corp. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003424	Pinnacle R/O II or Radifocus Introducer II	Terumo Medical Corp.	2000	—
0 (this device)	K062446	Modification to Pinnacle Roii Hiflow Introducer Sheath	Terumo Medical Corp.	2006	—

FIG. 1 — Lineage of K062446, 2000–2006Source: 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.

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

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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	Applicant	Decided	Recalls
*	K003424	Pinnacle R/O II or Radifocus Introducer II Summary page 2 …1H. PERFORMANCE The performance of the Pinnacle® ROLL HiFlow Introducer Sheath is substantially equivalent to the performance of the predicate device K003424. The equivalence was shown through bench testing. Terumo Medical Corporation Special 510(k) - Pinnacle® R…	Terumo Medical Corp.	2000	—

Also cleared against K003424: 1 other device →

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?

Its one ancestor has no recall.
1 other device also cites its predicate K003424.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

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® ROll HiFlow Introducer Sheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062446 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062446: Modification to Pinnacle Roii Hiflow Introducer Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062446

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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