510(k) · Cleared

Recalled · Class II · 2013

Transradial Artery Access Devices

K112554510(k) TraditionalCleared Nov 18, 201177-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

Teleflexmedical, Inc. · DYB Introducer, Catheter

Cleared on Nov 18, 2011 as substantially equivalent to K780532 (Arrow Intl., Inc., 1978) and 1 other predicate after a 77-day review. Its family tree reaches back 4 generations to 1995. 2 of the 11 devices in its family, counting itself, have a Class I recall. It has been recalled once.

Decided: Nov 18, 2011
Review: 77 days
Class: Class II
Product code: DYB
Recalls: 1
Predicates: 2

Its longest line of descent runs back 4 generations to K954234 (1995). 10 ancestors in all, the oldest K780532 (1978). No later device cites it as a predicate yet. 2 of the 11 devices in this family, counting this one, have 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 deviceK112554 Transradial Artery Access DevicesTeleflexmedical, Inc. · 2011

Class I recalls in this family

K780532 Percutaneous Sheath Introducer Kitdirect predicate · 1978
K810675 Arrow Radial Artery Catheterization Set3 generations back · 1981

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)	K112554	Transradial Artery Access Devices	Teleflexmedical, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	1
1981	1	1
1991	1	0
1993	1	0
1995	1	0
1996	1	0

FIG. 1 — Lineage of K112554, 1995–2011Source: 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

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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
*	K780532	Percutaneous Sheath Introducer Kit Summary page 1 …ntroducer Device classification Class 11, DYB, Introducer, Catheter, 21 CFR 870.1340 name: Legally marketed device Arrow Percutaneous Sheath Introducers, K780532 to which the device is Terumo GlidesheathTM Catheter Introducer Sheath, K082644 substantially equivalent: Description of…	Arrow Intl., Inc.	1978	Class I
*	K082644	Glidesheath Summary page 1 …0.1340 name: Legally marketed device Arrow Percutaneous Sheath Introducers, K780532 to which the device is Terumo GlidesheathTM Catheter Introducer Sheath, K082644 substantially equivalent: Description of the device: The TransRadial Artery Access devices are comprised of the…	Terumo Medical Corp.	2008	—

Also cleared against K780532: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 9, 2013	Class II	Z-0468-2014	Process control	There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.

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.

K780532Percutaneous Sheath Introducer KitArrow Intl., Inc. · 1978 · Direct predicate · ◆ in the 1978 ancestors bar of FIG. 11 Class I recall
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 16 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
3 of the 10 ancestors have a recall of any class; 2 have a Class I recall.
2 other devices also cite its predicate K780532.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 TransRadial Artery Access Device is intended for use for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112554 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112554: Transradial Artery Access Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112554

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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