510(k) · Cleared

Recalled · Class II · 2013

Glidesheath

K102008510(k) TraditionalCleared Jul 21, 20105-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 Jul 21, 2010 as substantially equivalent to K082644 (Terumo Medical Corp., 2008) after a 5-day review. Its family tree reaches back 4 generations to 1995. 1 of the 27 devices in its family, counting itself, has a Class I recall. 17 later devices descend from it. It has been recalled once.

Decided: Jul 21, 2010
Review: 5 days
Class: Class II
Product code: DYB
Recalls: 1
Predicates: 1

Its longest line of descent runs back 4 generations to K954234 (1995). 9 ancestors in all, the oldest K810675 (1981). 17 later devices descend from it, 3 citing it directly. 1 of the 27 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 4 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
3 generations backK033681 GlidesheathTerumo Corp. · 2003
2 generations backK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
1 generation backK082644 GlidesheathTerumo Medical Corp. · 2008
This deviceK102008 GlidesheathTerumo Medical Corp. · 2010
Descendant · cites it directly · 7 of its ownK111606 Pinnacle Precision Access SystemTerumo Medical Corp. · 2011 · Recalled
Descendant · cites it directly · 6 of its ownK140543 Preludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2014 · Recalled
Descendant · 2 generations on · 5 of its ownK150257 PreludeEASE Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2015
Descendant · 2 generations on · 4 of its ownK173750 Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2018 · Recalled
Descendant · 2 generations on · 3 of its ownK123475 Shoocin Introducer KitLepu Medical Technology (Beijing) Co., Ltd. · 2014

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2011high 3 (2014) · low 0 (2012)2026

Class I recalls in this family

K810675 Arrow Radial Artery Catheterization Set3 generations back · 1981

Most influential descendants

Showing 5 of 17 · See all

K111606Pinnacle Precision Access SystemTerumo Medical Corp. · 2011 · cites it directly7descendants
K140543Preludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2014 · cites it directly6descendants
K150257PreludeEASE Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2015 · 2 generations on5descendants
K173750Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2018 · 2 generations on4descendants
K123475Shoocin Introducer KitLepu Medical Technology (Beijing) Co., Ltd. · 2014 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K954234	Radifocus Introducer II Kit	Terumo Medical Corp.	1995	—
−3	K033681	Glidesheath	Terumo Corp.	2003	—
−2	K062858	Modification to Glidesheath	Terumo Medical Corp.	2006	—
−1	K082644	Glidesheath	Terumo Medical Corp.	2008	—
0 (this device)	K102008	Glidesheath	Terumo Medical Corp.	2010	—
+1	K111606	Pinnacle Precision Access System	Terumo Medical Corp.	2011	1
+1	K140543	Preludeease Hydrophilic Sheath Introducer	Merit Medical Systems, Inc.	2014	1
+2	K150257	PreludeEASE Hydrophilic Sheath Introducer	Merit Medical Systems, Inc.	2015	—
+2	K173750	Prelude IDeal Hydrophilic Sheath Introducer	Merit Medical Systems, Inc.	2018	2
+2	K123475	Shoocin Introducer Kit	Lepu Medical Technology (Beijing) Co., Ltd.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	1
1991	1	0
1993	1	0
1995	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2014	3	0
2015	2	0
2017	2	0
2018	2	0
2022	1	0
2023	1	0
2024	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K102008, 1995–2026Source: 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.

1 device in this family has 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? (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
*	K082644	Glidesheath Summary page 3 …function in the same manner. Differences in materials between the Glidesheath device covered in this submission and the predicate device, cleared under K082644, raise no new issues of safety or effectiveness. F. Specific adins Sheath Size…	Terumo Medical Corp.	2008	—

Also cleared against K082644: 8 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K111606	Pinnacle Precision Access System	Terumo Medical Corp.	2011	7
K140543	Preludeease Hydrophilic Sheath Introducer	Merit Medical Systems, Inc.	2014	6
K111263	Cxi Triforce	Cook Incorporated	2011	1

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 30, 2013	Class II	Z-1612-2013	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.

K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · 3 generations back · ◆ in the 1981 ancestors bar of FIG. 11 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 2.9 years on median.
2 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K111606 (Terumo Medical Corp., 2011) has gone furthest, with 7 descendants of its own.
8 other devices also cite its predicate K082644.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

The Entry Needle is an accessory device which is used to gain access to the vein or artery including but not limited to the radial artery, for placement of the Mini Guide Wire.

The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102008 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102008: Glidesheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102008

Report an extraction error

Are you the manufacturer?

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