510(k) · Cleared

Cleared

Halo One Thin-Walled Guiding Sheath

K212708510(k) SpecialCleared Sep 23, 202128-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

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

Cleared on Sep 23, 2021 as substantially equivalent to K192313 (C.R. Bard, Inc., 2019) after a 28-day review. Its family tree reaches back 3 generations to 1998. 1 of the 4 devices in its family, counting itself, has a Class I recall.

Decided: Sep 23, 2021
Review: 28 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K984500 (1998). No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK984500 Cordis Brite Tip Catheter Sheath Introducer SystemCordis Corp. · 1998 · Recalled
2 generations backK161183 Halo One Thin-Walled Guiding SheathC.R. Bard, Inc. · 2016 · Recalled (Class I)
1 generation backK192313 Halo One Thin-Walled Guiding SheathC.R. Bard, Inc. · 2019
This deviceK212708 Halo One Thin-Walled Guiding SheathC.R. Bard, Inc. · 2021

Class I recalls in this family

K161183 Halo One Thin-Walled Guiding Sheath2 generations back · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K984500	Cordis Brite Tip Catheter Sheath Introducer System	Cordis Corp.	1998	1
−2	K161183	Halo One Thin-Walled Guiding Sheath	C.R. Bard, Inc.	2016	Class I
−1	K192313	Halo One Thin-Walled Guiding Sheath	C.R. Bard, Inc.	2019	—
0 (this device)	K212708	Halo One Thin-Walled Guiding Sheath	C.R. Bard, Inc.	2021	—

FIG. 1 — Lineage of K212708, 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

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
*	K192313	Halo One Thin-Walled Guiding Sheath Summary page 4 …Regulation Number: 21 CFR 870.1340 Classification Panel: Cardiovascular Predicate Device: 510(k) Number: K192313 Name of Device: Halo One Thin-Walled Guiding Sheath Common or Usual Name: Catheter, Int…	C.R. Bard, Inc.	2019	—

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

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.

K161183Halo One Thin-Walled Guiding SheathC.R. Bard, Inc. · 2016 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls

What does this lineage say?

The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
2 of the 3 ancestors have a recall of any class; 1 has a Class I recall.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K212708 · printed Nov 6, 2026

Cite this page

510(k) Report. “K212708: 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/K212708

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