510(k) · Cleared

Cleared

Ptfe Interlock Peelable Introducers

K081394510(k) SpecialCleared Sep 15, 2008119-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

Enpath Medical, Inc. · DYB Introducer, Catheter

Cleared on Sep 15, 2008 as substantially equivalent to K000824 (Medamicus, Inc., 2000) after a 119-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.

Decided: Sep 15, 2008
Review: 119 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K000824 (2000). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK000824 Percutaneous Introducer, Model 10383-XXXMedamicus, Inc. · 2000
This deviceK081394 Ptfe Interlock Peelable IntroducersEnpath Medical, Inc. · 2008
Descendant · cites it directly · 2 of its ownK093023 Ptfe Peelable IntroducerGreat Batch Medical · 2009
Descendant · 2 generations on · 1 of its ownK102540 Ptfe Portable IntroducerGreat Batch Medical · 2010
Descendant · 3 generations on · 0 of its ownK123974 Percutaneous Introducer KitTeleflex, Inc. · 2013

Most influential descendants

Showing 3 of 3 · See all

K093023Ptfe Peelable IntroducerGreat Batch Medical · 2009 · cites it directly2descendants
K102540Ptfe Portable IntroducerGreat Batch Medical · 2010 · 2 generations on1descendant
K123974Percutaneous Introducer KitTeleflex, Inc. · 2013 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000824	Percutaneous Introducer, Model 10383-XXX	Medamicus, Inc.	2000	—
0 (this device)	K081394	Ptfe Interlock Peelable Introducers	Enpath Medical, Inc.	2008	—
+1	K093023	Ptfe Peelable Introducer	Great Batch Medical	2009	—
+2	K102540	Ptfe Portable Introducer	Great Batch Medical	2010	—
+3	K123974	Percutaneous Introducer Kit	Teleflex, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2013	1	0

FIG. 1 — Lineage of K081394, 2000–2013Source: 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
*	K000824	Percutaneous Introducer, Model 10383-XXX Summary page 1 …nce standards applicable to this product have been developed under Section 514 of the Act. Predicate Device Enpath Medical, Inc. Percutaneous Introducer (K000824) Device Description The Enpath Medical PTFE Peelable Introducer kit consists of a disposable needle, a disposable…	Medamicus, Inc.	2000	—

Also cleared against K000824: 1 other device →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K093023	Ptfe Peelable Introducer	Great Batch Medical	2009	2

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 no recall.
Of its descendants, K093023 (Great Batch Medical, 2009) has gone furthest, with 2 descendants of its own.
1 other device also cites its predicate K000824.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 PTFE 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/K081394 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081394: Ptfe Interlock Peelable Introducers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081394

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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