510(k) · Cleared

Recalled · 2010

Carotid Guiding Sheath

K012812510(k) TraditionalCleared Nov 14, 200184-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 Nov 14, 2001 as substantially equivalent to K924607 (Arrow Intl., Inc., 1993) after an 84-day review. Its family tree reaches back 1 generation to 1993. 2 of the 71 devices in its family, counting itself, have a Class I recall. 69 later devices descend from it. It has been recalled once.

Decided: Nov 14, 2001
Review: 84 days
Class: Class II
Product code: DYB
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K924607 (1993). 69 later devices descend from it, 3 citing it directly. 2 of the 71 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
This deviceK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001
Descendant · cites it directly · 60 of its ownK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
Descendant · 2 generations on · 44 of its ownK080415 Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2008
Descendant · 2 generations on · 30 of its ownK091329 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2009 · Recalled
Descendant · 3 generations on · 13 of its ownK142829 Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor…Cook Incorporated · 2015 · Recalled (Class I)
Descendant · 2 generations on · 13 of its ownK081341 Reinforced Catheter Introducer System (Rcis)Thomas Medical Products, Inc. · 2008

Showing 5 of 69 descendants. See all descendants

Descendants cleared per year

2005high 8 (2015) · low 0 (2019)2026

Class I recalls in this family

K150186 Chariot Guiding Sheath3 generations on · 2015
K142829 Flexor Tuohy-Borst Side-Arm Introducer, Ansel…3 generations on · 2015

Most influential descendants

Showing 5 of 69 · See all

K051601Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005 · cites it directly60descendants
K080415Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2008 · 2 generations on44descendants
K091329Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2009 · 2 generations on30descendants
K142829Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer…Cook Incorporated · 2015 · 3 generations on13descendants
K081341Reinforced Catheter Introducer System (Rcis)Thomas Medical Products, Inc. · 2008 · 2 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924607	Arrow Fischell Kink Resist Percut Sheath Intro Set	Arrow Intl., Inc.	1993	3
0 (this device)	K012812	Carotid Guiding Sheath	Terumo Medical Corp.	2001	—
+1	K051601	Pinnacle Destination Peripheral Guiding Sheath	Terumo Medical Corp.	2005	—
+2	K080415	Device Modification to Pinnacle Destination Peripheral Guiding Sheath	Terumo Medical Corp.	2008	—
+2	K091329	Pinnacle Destination Peripheral Guiding Sheath	Terumo Medical Corp.	2009	1
+3	K142829	Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo…	Cook Incorporated	2015	Class I
+2	K081341	Reinforced Catheter Introducer System (Rcis)	Thomas Medical Products, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	1	0
2007	1	0
2008	3	0
2009	4	0
2010	2	0
2011	1	0
2012	3	0
2013	2	0
2014	2	0
2015	8	2
2016	6	0
2017	3	0
2018	4	0
2020	4	0
2021	6	0
2022	2	0
2023	2	0
2024	4	0
2025	5	0
2026	4	0

FIG. 1 — Lineage of K012812, 1993–2026Source: 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.

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

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
*	K924607	Arrow Fischell Kink Resist Percut Sheath Intro Set Summary page 1 …w-Flex Percutaneous Sheath Introducer Set, which is manufactured by Arrow International, Inc. The Super Arrow-flex is cleared through the premarket notification process (K924607). C. INTENDED USE The Carotid Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the…	Arrow Intl., Inc.	1993	3

Also cleared against K924607: 7 other devices →

What descends from it? (69)

See all 69

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

Number	Device	Applicant	Decided	Descendants
K051601	Pinnacle Destination Peripheral Guiding Sheath	Terumo Medical Corp.	2005	60
K052185	Destination Carotid Guiding Sheath	Terumo Medical Corp.	2005	7
K060666	Carotid Access Kit	Terumo Medical Corp.	2006	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 24, 2010	Not classified	Z-2415-2011	Equipment maintenance	Molding defect in destination product that render the device unusable.

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.

K150186Chariot Guiding SheathBoston Scientific Corp · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K142829Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification…Cook Incorporated · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 121 Class I recalls

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K051601 (Terumo Medical Corp., 2005) has gone furthest, with 60 descendants of its own.
7 other devices also cite its predicate K924607.

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)	—

What is it indicated for?

The Carotid Guiding Sheath is intended for the introduction of interventional

and diagnostic devices into the human vasculature including but not limited to

the carotid arteries.

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/K012812 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012812: Carotid Guiding Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012812

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026