510(k) · Cleared

Recalled · Class II · 2015

Renal Guiding Sheath

K012854510(k) TraditionalCleared Nov 21, 200189-day reviewClass II21 CFR 870.1340Recalls 2

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 21, 2001 as substantially equivalent to K924607 (Arrow Intl., Inc., 1993) after an 89-day review. Its family tree reaches back 1 generation to 1993. 8 later devices descend from it. It has been recalled 2 times.

Decided: Nov 21, 2001
Review: 89 days
Class: Class II
Product code: DYB
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K924607 (1993). 8 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
This deviceK012854 Renal Guiding SheathTerumo Medical Corp. · 2001
Descendant · cites it directly · 5 of its ownK081045 Destination Renal Guiding SheathTerumo Medical Corp. · 2008
Descendant · 2 generations on · 2 of its ownK122958 Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2012 · Recalled
Descendant · 3 generations on · 1 of its ownK210627 Breezeway IIOscor, Inc. · 2021
Descendant · cites it directly · 1 of its ownK033569 Flowmedica Bifurcated Infusion System, Infusion Catheter and…Flowmedica, Inc. · 2004 · Recalled
Descendant · 4 generations on · 0 of its ownK242756 Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075…Pulnovo Medical (Wuxi) Co., Ltd. · 2024

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2004high 2 (2008) · low 0 (2005)2026

Most influential descendants

Showing 5 of 8 · See all

K081045Destination Renal Guiding SheathTerumo Medical Corp. · 2008 · cites it directly5descendants
K122958Delivery Sheath, Model Adelante BreezewayOscor, Inc. · 2012 · 2 generations on2descendants
K210627Breezeway IIOscor, Inc. · 2021 · 3 generations on1descendant
K033569Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathFlowmedica, Inc. · 2004 · cites it directly1descendant
K242756Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090…Pulnovo Medical (Wuxi) Co., Ltd. · 2024 · 4 generations on0descendants

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)	K012854	Renal Guiding Sheath	Terumo Medical Corp.	2001	—
+1	K081045	Destination Renal Guiding Sheath	Terumo Medical Corp.	2008	—
+2	K122958	Delivery Sheath, Model Adelante Breezeway	Oscor, Inc.	2012	30
+3	K210627	Breezeway II	Oscor, Inc.	2021	—
+1	K033569	Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath	Flowmedica, Inc.	2004	2
+4	K242756	Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080…	Pulnovo Medical (Wuxi) Co., Ltd.	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2008	2	0
2012	1	0
2014	1	0
2017	1	0
2021	1	0
2024	1	0

FIG. 1 — Lineage of K012854, 1993–2024Source: 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.

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? (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 Renal Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the h…	Arrow Intl., Inc.	1993	3

Also cleared against K924607: 7 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K081045	Destination Renal Guiding Sheath	Terumo Medical Corp.	2008	5
K033569	Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath	Flowmedica, Inc.	2004	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 6, 2015	Class II	Z-2033-2017	Other	Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents…
Jun 24, 2010	Not classified	Z-2417-2011	Equipment maintenance	Molding defect in destination product that render the device unusable.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K081045 (Terumo Medical Corp., 2008) has gone furthest, with 5 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 Renal Guiding Sheath is intended for the introduction of interventional

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

the renal 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/K012854 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012854: Renal Guiding Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012854

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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