510(k) · Cleared

Cleared

Edwards Percutaneous Sheath Introducer

K121185510(k) TraditionalCleared Aug 22, 2012126-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

Edwards Lifesciences, LLC · DYB Introducer, Catheter

Cleared on Aug 22, 2012 as substantially equivalent to K981909 (Baxter Edwards, 1998) after a 126-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.

Decided: Aug 22, 2012
Review: 126 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K981909 (1998). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK981909 Baxter Hemostasis Valve IntroducersBaxter Edwards · 1998 · Recalled
This deviceK121185 Edwards Percutaneous Sheath IntroducerEdwards Lifesciences, LLC · 2012
Descendant · cites it directly · 0 of its ownK133296 XCATHAlseal · 2014

Most influential descendants

Showing 1 of 1 · See all

K133296XCATHAlseal · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K981909	Baxter Hemostasis Valve Introducers	Baxter Edwards	1998	3
0 (this device)	K121185	Edwards Percutaneous Sheath Introducer	Edwards Lifesciences, LLC	2012	—
+1	K133296	XCATH	Alseal	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K121185, 1998–2014Source: 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

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
*	K981909	Baxter Hemostasis Valve Introducers Summary page 1 …ification Name: Catheter Introducer 21 CIFR Part 870.1340, Product Code DYB, Class 11 Predicate Device: K981909: Baxter Hemostasis Valve Introducer Device Description: The triple lumen percutaneous sheath introducer is used to access the v…	Baxter Edwards	1998	3

Also cleared against K981909: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K133296	XCATH	Alseal	2014	0

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K133296 (Alseal, 2014) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K981909.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Edwards Percutaneous Sheath Introducer is indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121185 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121185: Edwards Percutaneous 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/K121185

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