510(k) · Cleared

Cleared

Nexgen Expandable Catheter

K102925510(k) TraditionalCleared Nov 10, 2011402-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

Nexgen Medical Systems, Inc. · DYB Introducer, Catheter

Cleared on Nov 10, 2011 as substantially equivalent to K070865 (Applied Medical, 2007) after a 402-day review. Its family tree reaches back 3 generations to 1989.

Decided: Nov 10, 2011
Review: 402 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K890766 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK890766 Catheter Introducer SheathApplied Vascular Devices, Inc. · 1989
2 generations backK963886 EVSApplied Medical Resources · 1997
1 generation backK070865 Expanding Vascular SheathApplied Medical · 2007
This deviceK102925 Nexgen Expandable CatheterNexgen Medical Systems, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K890766	Catheter Introducer Sheath	Applied Vascular Devices, Inc.	1989	—
−2	K963886	EVS	Applied Medical Resources	1997	—
−1	K070865	Expanding Vascular Sheath	Applied Medical	2007	—
0 (this device)	K102925	Nexgen Expandable Catheter	Nexgen Medical Systems, Inc.	2011	—

FIG. 1 — Lineage of K102925, 1989–2011Source: 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K961886	FDA’s K961886 is Drager Gemina Wall-Mounted Workplace Our reading of the summary gave K961886, FDA’s number for Drager Gemina Wall-Mounted Workplace (Alm Surgical Equipment, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Applied Medical Expandable Vascular Sheath”. Kept off the family tree. Summary page 2 …d 11Imm, each having a working length of 43cm and 11l6cm. The Nex~en Expandable Catheter is substantially equivalent to the Applied Medical Expandable Vascular Sheath (K961 886 and K070865). Mechanical, safety and biocompatibility tests were performed to verify the functional safety, structural integrity…	Alm Surgical Equipment, Inc.	1996	—
*	K070865	Expanding Vascular Sheath Summary page 1 …ATEMENT: Predicate Device: The Nex~en Peripheral Expandable Catheter is substantially equivalent to the Applied Medical Expandable Vascular Sheath cleared under 5110(k) K070865 and K963886. Device Description: The NexGen Peripheral Expandable Catheter is a sterile single use catheter intended to facilita…	Applied Medical	2007	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 7.6 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 NexGen Peripheral Expandable Catheter is indicated for percutaneous access to the peripheral vascular systemn and is designed to assist in the placement and removal of devices. This device is not intended for use in the coronary or cerebral vasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102925 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102925: Nexgen Expandable Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102925

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