510(k) · Cleared

Recalled · Class I · 2016

Halo One Thin-Walled Guiding Sheath

K161183510(k) TraditionalCleared Jun 3, 201637-day reviewClass II21 CFR 870.1340Recalls 3 (3 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

C.R. Bard, Inc. · DYB Introducer, Catheter

Cleared on Jun 3, 2016 as substantially equivalent to K984500 (Cordis Corp., 1998) after a 37-day review. Its family tree reaches back 1 generation to 1998. 1 of the 4 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 3 times, including 3 Class I recalls.

Decided: Jun 3, 2016
Review: 37 days
Class: Class II
Product code: DYB
Recalls: 3 (3 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to K984500 (1998). 2 later devices descend from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK984500 Cordis Brite Tip Catheter Sheath Introducer SystemCordis Corp. · 1998 · Recalled
This deviceK161183 Halo One Thin-Walled Guiding SheathC.R. Bard, Inc. · 2016
Descendant · cites it directly · 1 of its ownK192313 Halo One Thin-Walled Guiding SheathC.R. Bard, Inc. · 2019
Descendant · 2 generations on · 0 of its ownK212708 Halo One Thin-Walled Guiding SheathC.R. Bard, Inc. · 2021

Most influential descendants

Showing 2 of 2 · See all

K192313Halo One Thin-Walled Guiding SheathC.R. Bard, Inc. · 2019 · cites it directly1descendant
K212708Halo One Thin-Walled Guiding SheathC.R. Bard, Inc. · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K984500	Cordis Brite Tip Catheter Sheath Introducer System	Cordis Corp.	1998	1
0 (this device)	K161183	Halo One Thin-Walled Guiding Sheath	C.R. Bard, Inc.	2016	—
+1	K192313	Halo One Thin-Walled Guiding Sheath	C.R. Bard, Inc.	2019	—
+2	K212708	Halo One Thin-Walled Guiding Sheath	C.R. Bard, Inc.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2021	1	0

FIG. 1 — Lineage of K161183, 1998–2021Source: 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

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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
*	K984500	Cordis Brite Tip Catheter Sheath Introducer System Summary page 4 …B) Classification: Class II Classification Panel: Cardiovascular Predicate Device:  Cordis Brite Tip Catheter Sheath Introducer System: (K984500, cleared December 23, 1998) K161…	Cordis Corp.	1998	1

Also cleared against K984500: 3 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K192313	Halo One Thin-Walled Guiding Sheath	C.R. Bard, Inc.	2019	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 2, 2016	Class I	Z-0968-2017	Device Design	Complaints of sheath separation, kinking, and/or tip damage during use.
Dec 2, 2016	Class I	Z-0969-2017	Device Design	Complaints of sheath separation, kinking, and/or tip damage during use.
Dec 2, 2016	Class I	Z-0970-2017	Device Design	Complaints of sheath separation, kinking, and/or tip damage during use.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K192313 (C.R. Bard, Inc., 2019) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K984500.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K161183 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161183: Halo One Thin-Walled Guiding Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161183

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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