510(k) · Cleared

Recalled · 2003

Cordis Brite Tip Sheath Introducer

K954595510(k) TraditionalCleared Dec 28, 199586-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

Cordis Corp. · DYB Introducer, Catheter

Cleared on Dec 28, 1995 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 28 later devices descend from it. It has been recalled once.

Decided: Dec 28, 1995
Review: 86 days
Class: Class II
Product code: DYB
Recalls: 1
Predicates: 0

28 later devices descend from it, 2 citing it directly.

This deviceK954595 Cordis Brite Tip Sheath IntroducerCordis Corp. · 1995
Descendant · cites it directly · 25 of its ownK970392 Cordis Avanti+Catheter Sheath Introducer SystemCordis Corp. · 1997 · Recalled
Descendant · 2 generations on · 24 of its ownK050962 Merit Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2005 · Recalled
Descendant · 3 generations on · 22 of its ownK070159 Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2007 · Recalled
Descendant · 4 generations on · 12 of its ownK091006 Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · Recalled
Descendant · 5 generations on · 11 of its ownK100615 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

1997high 4 (2010) · low 0 (1999)2026

Most influential descendants

Showing 5 of 28 · See all

K970392Cordis Avanti+Catheter Sheath Introducer SystemCordis Corp. · 1997 · cites it directly25descendants
K050962Merit Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2005 · 2 generations on24descendants
K070159Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2007 · 3 generations on22descendants
K091006Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · 4 generations on12descendants
K100615Arstasis Access SystemArstasis, Inc. · 2010 · 5 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K954595	Cordis Brite Tip Sheath Introducer	Cordis Corp.	1995	—
+1	K970392	Cordis Avanti+Catheter Sheath Introducer System	Cordis Corp.	1997	2
+2	K050962	Merit Prelude Sheath Introducer	Merit Medical Systems, Inc.	2005	1
+3	K070159	Prelude Sheath Introducer	Merit Medical Systems, Inc.	2007	3
+4	K091006	Itg Vascular Access System, Model 300	Arstasis, Inc.	2010	1
+5	K100615	Arstasis Access System	Arstasis, Inc.	2010	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
1998	1	0
2005	1	0
2007	1	0
2010	4	0
2011	3	0
2012	1	0
2013	3	0
2014	4	0
2015	2	0
2016	1	0
2018	1	0
2022	1	0
2023	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K954595, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (28)

See all 28

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

Number	Device	Applicant	Decided	Descendants
K970392	Cordis Avanti+Catheter Sheath Introducer System	Cordis Corp.	1997	25
K971608	Cordis Brite Tip Catheter Sheath Introducer System	Cordis Corp.	1997	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 5, 2003	Not classified	Z-0941-03	Other	Reports of broken or separated tips of the catheter sheath introducers.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K970392 (Cordis Corp., 1997) has gone furthest, with 25 descendants of its own.

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)	—

https://510kreport.com/device/K954595 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954595: Cordis Brite Tip Sheath Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954595

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026