510(k) · Cleared

Cleared

Pinnacle Roii Introducer Sheath

K082847510(k) SpecialCleared Oct 29, 200830-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 29, 2008 as substantially equivalent to K003424 (Terumo Medical Corp., 2000) after a 30-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.

Decided: Oct 29, 2008
Review: 30 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003424 (2000). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK003424 Pinnacle R/O II or Radifocus Introducer IITerumo Medical Corp. · 2000
This deviceK082847 Pinnacle Roii Introducer SheathTerumo Medical Corp. · 2008
Descendant · cites it directly · 2 of its ownK132592 Flexor Radial Hydrophilic Introducer Access SetCook, Inc. · 2014 · Recalled
Descendant · 2 generations on · 1 of its ownK152044 Flexor Radial Hydrophilic Introducer Access SetCook Incorporated · 2015
Descendant · 3 generations on · 0 of its ownK171609 Check-Flo Performer Introducer Micropuncture Radial Artery Access SetCook Incorporated · 2018

Most influential descendants

Showing 3 of 3 · See all

K132592Flexor Radial Hydrophilic Introducer Access SetCook, Inc. · 2014 · cites it directly2descendants
K152044Flexor Radial Hydrophilic Introducer Access SetCook Incorporated · 2015 · 2 generations on1descendant
K171609Check-Flo Performer Introducer Micropuncture Radial Artery Access SetCook Incorporated · 2018 · 3 generations on0descendants

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)	K082847	Pinnacle Roii Introducer Sheath	Terumo Medical Corp.	2008	—
+1	K132592	Flexor Radial Hydrophilic Introducer Access Set	Cook, Inc.	2014	7
+2	K152044	Flexor Radial Hydrophilic Introducer Access Set	Cook Incorporated	2015	—
+3	K171609	Check-Flo Performer Introducer Micropuncture Radial Artery Access Set	Cook Incorporated	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	1	0
2018	1	0

FIG. 1 — Lineage of K082847, 2000–2018Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K003424	Pinnacle R/O II or Radifocus Introducer II Summary page 2 …ice is the Pinnacle® ROIl, which is manufactured by Terumo Medical Corporation. The Pinnacle® ROII is cleared through the premarket notification process (K003424). C. INTENDED USE The Pinnacle® ROII Introducer Sheath is used to facilitate placing a catheter through the…	Terumo Medical Corp.	2000	—

Also cleared against K003424: 1 other device →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K132592	Flexor Radial Hydrophilic Introducer Access Set	Cook, Inc.	2014	2

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.
Of its descendants, K132592 (Cook, Inc., 2014) has gone furthest, with 2 descendants of its own.
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. 2008, 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 ® ROIl 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/K082847 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082847: Pinnacle Roii Introducer Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082847

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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