510(k) · Cleared

Recalled · Class I · 2026

Introducer Set, Model Adelante-S Series

K122084510(k) SpecialCleared Aug 29, 201244-day reviewClass II21 CFR 870.1340Recalls 4 (3 Class I)

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

Oscor, Inc. · DYB Introducer, Catheter

Cleared on Aug 29, 2012 as substantially equivalent to K934901 (Thomas Medical Products, Inc., 1994) after a 44-day review. Its family tree reaches back 1 generation to 1994. 3 of the 4 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 4 times, including 3 Class I recalls.

Decided: Aug 29, 2012
Review: 44 days
Class: Class II
Product code: DYB
Recalls: 4 (3 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to K934901 (1994). 2 later devices descend from it, 2 citing it directly. 3 of the 4 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK934901 Tear-Away Sheath Introducer Set with Integral Hemostasis ValveThomas Medical Products, Inc. · 1994 · Recalled
This deviceK122084 Introducer Set, Model Adelante-S SeriesOscor, Inc. · 2012
Descendant · cites it directly · 0 of its ownK201116 Abiomed 23 Fr SheathAbiomed, Inc. · 2020 · Recalled (Class I)
Descendant · cites it directly · 0 of its ownK192769 Impella CP IntroducerAbiomed, Inc. · 2019 · Recalled (Class I)

Class I recalls in this family

K192769 Impella CP Introducercites it directly · 2019
K201116 Abiomed 23 Fr Sheathcites it directly · 2020

Most influential descendants

Showing 2 of 2 · See all

K201116Abiomed 23 Fr SheathAbiomed, Inc. · 2020 · cites it directly0descendants
K192769Impella CP IntroducerAbiomed, Inc. · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934901	Tear-Away Sheath Introducer Set with Integral Hemostasis Valve	Thomas Medical Products, Inc.	1994	7
0 (this device)	K122084	Introducer Set, Model Adelante-S Series	Oscor, Inc.	2012	—
+1	K201116	Abiomed 23 Fr Sheath	Abiomed, Inc.	2020	Class I
+1	K192769	Impella CP Introducer	Abiomed, Inc.	2019	Class I

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	1
2020	1	1

FIG. 1 — Lineage of K122084, 1994–2020Source: 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.

3 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

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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
*	K934901	Tear-Away Sheath Introducer Set with Integral Hemostasis Valve Summary page 1 …Predicate Devices: Tearaway Sheath Introducer Set with Integral Hemostaris Valve (K934901) Device Description: The components of the SafeSheath MSP h Introducer Kit…	Thomas Medical Products, Inc.	1994	7

Also cleared against K934901: 2 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K201116	Abiomed 23 Fr Sheath Class I	Abiomed, Inc.	2020	0
K192769	Impella CP Introducer Class I	Abiomed, Inc.	2019	0

Has anything in its family been recalled? (3 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 10, 2026	Class I	Z-2680-2026	Device Design	Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Jun 10, 2026	Class I	Z-2678-2026	Device Design	Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Jun 10, 2026	Class I	Z-2679-2026	Device Design	Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Feb 22, 2021	Class II	Z-1467-2021	Under Investigation by firm	AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified…

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.

K192769Impella CP IntroducerAbiomed, Inc. · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls
K201116Abiomed 23 Fr SheathAbiomed, Inc. · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 113 Class I recalls

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K201116 (Abiomed, Inc., 2020) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K934901.

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 introducer sets, Adelante®-S Series are intended for introduction of pacing leads or catheters into the body.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122084 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122084: Introducer Set, Model Adelante-S Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122084

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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