510(k) · Cleared

Cleared

Valved Peelable Introducer

K021004510(k) TraditionalCleared Jun 6, 200270-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

Medamicus, Inc. · DYB Introducer, Catheter

Cleared on Jun 6, 2002 as substantially equivalent to K932323 (Medamicus, Inc., 1993) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1993. 21 later devices descend from it.

Decided: Jun 6, 2002
Review: 70 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K932323 (1993). 2 ancestors in all. 21 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
This deviceK021004 Valved Peelable IntroducerMedamicus, Inc. · 2002
Descendant · cites it directly · 20 of its ownK030905 Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2003
Descendant · 2 generations on · 19 of its ownK040150 Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2004
Descendant · 3 generations on · 12 of its ownK090394 Valved Tearway IntroducerMedcomp · 2009
Descendant · 3 generations on · 4 of its ownK122422 Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx…Care Fusion · 2012
Descendant · 4 generations on · 2 of its ownK160437 PleurX Peritoneal Catheter SystemCare Fusion · 2016

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2003high 3 (2012) · low 0 (2005)2026

Most influential descendants

Showing 5 of 21 · See all

K030905Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2003 · cites it directly20descendants
K040150Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2004 · 2 generations on19descendants
K090394Valved Tearway IntroducerMedcomp · 2009 · 3 generations on12descendants
K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…Care Fusion · 2012 · 3 generations on4descendants
K160437PleurX Peritoneal Catheter SystemCare Fusion · 2016 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K932323	Percutaneous Introducer	Medamicus, Inc.	1993	—
0 (this device)	K021004	Valved Peelable Introducer	Medamicus, Inc.	2002	—
+1	K030905	Medamicus Flowguard Peelable Introducer	Medamicus, Inc.	2003	—
+2	K040150	Modification to Medamicus Flowguard Peelable Introducer	Medamicus, Inc.	2004	—
+3	K090394	Valved Tearway Introducer	Medcomp	2009	—
+3	K122422	Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved…	Care Fusion	2012	—
+4	K160437	PleurX Peritoneal Catheter System	Care Fusion	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	2	0
2006	1	0
2007	1	0
2009	1	0
2010	1	0
2012	3	0
2013	3	0
2015	1	0
2016	3	0
2017	1	0
2018	1	0
2020	1	0
2024	1	0

FIG. 1 — Lineage of K021004, 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? (2)

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
*	K932323	Percutaneous Introducer Summary page 1 …Catheter Introducer Classification Name Introducer, Percutaneous Predicate Device MedAmicus Percutaneous Introducer, K932323 MedAinicus Percutaneous Introducer, Material Change KO00824 Page 5 of 17 MedAmicus Valved Peela…	Medamicus, Inc.	1993	—
*	K000824	Percutaneous Introducer, Model 10383-XXX Summary page 2 …eedle and syringe. This configuration and specification remains the same as the configuration and specification that was previously cleared under K932323 and K000824. The Polystyrene tray is commonplace in the medical industry as a packaging material for a number of medical devices…	Medamicus, Inc.	2000	—

Also cleared against K932323: 1 other device →

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K030905	Medamicus Flowguard Peelable Introducer	Medamicus, Inc.	2003	20

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?

None of the 2 ancestors has a recall.
Of its descendants, K030905 (Medamicus, Inc., 2003) has gone furthest, with 20 descendants of its own.
1 other device also cites its predicate K932323.

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 MedAmicus Valved Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021004 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021004: Valved Peelable Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021004

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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