510(k) · Cleared

Cleared

Edwards Transfemoral Balloon Catheter

K140241510(k) TraditionalCleared Jul 3, 2014154-day reviewClass II21 CFR 870.1255

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

Edwards Lifesciences, LLC · OZT Balloon Aortic Valvuloplasty

Cleared on Jul 3, 2014 as substantially equivalent to K121083 (Loma Vista Medical, 2012) and 1 other predicate after a 154-day review. Its family tree reaches back 1 generation to 2012. 1 later device descends from it.

Decided: Jul 3, 2014
Review: 154 days
Class: Class II
Product code: OZT
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K122012 (2012). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK122012 Z-Med Z-Med IINuMED, Inc. · 2012
This deviceK140241 Edwards Transfemoral Balloon CatheterEdwards Lifesciences, LLC · 2014
Descendant · cites it directly · 0 of its ownK231814 ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc. · 2023

Most influential descendants

Showing 1 of 1 · See all

K231814ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc. · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K122012	Z-Med Z-Med II	NuMED, Inc.	2012	—
0 (this device)	K140241	Edwards Transfemoral Balloon Catheter	Edwards Lifesciences, LLC	2014	—
+1	K231814	ValvuloPro Valvuloplasty Balloon Catheter	Dongguan TT Medical, Inc.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0

FIG. 1 — Lineage of K140241, 2012–2023Source: 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 OZT? 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 OZT device

#1 K253855 KardiaPSI Balloon Catheterscore 11.3 · 1 generation · 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K121083	True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20MM X 4.5CM, True… Summary page 1 …Classification: Catheter Introducer . 21 CFR 870.1250, Product Code OZT Predicate Loma Vista Medical (BARD) TRUE Dilation Balioon Valvuloplasty Device(s): - Catheter (K121083), and the Z-MED and Z-MED II™ Balloon Aortic Valvuloplasty & Percutaneous Transluminal Valvuloplasty Catheter (K122012). - Devic…	Loma Vista Medical	2012	1
*	K122012	Z-Med Z-Med II Summary page 1 …tion Balioon Valvuloplasty Device(s): - Catheter (K121083), and the Z-MED and Z-MED II™ Balloon Aortic Valvuloplasty & Percutaneous Transluminal Valvuloplasty Catheter (K122012). - Device Description: The Edwards Balloon Catheter, is used for balloon aortic valvuloplasty. The device consists of a nylon…	NuMED, Inc.	2012	—

Also cleared against K121083: 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
K231814	ValvuloPro Valvuloplasty Balloon Catheter	Dongguan TT Medical, Inc.	2023	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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K231814 (Dongguan TT Medical, Inc., 2023) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K121083.

How does its category compare?

All OZT devices

OZT Balloon Aortic Valvuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · OZT

1in 2025

2007high 4 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OZT

115in 2015

2007high 115 (2015) · low 79 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OZT

No recall names OZT since 2007.

Adverse event reports per year · OZT

34in 2025

2007high 47 (2023) · low 0 (2007)2025

MAUDE reports naming product code OZT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	3	—	0
2013	3	80	29
2014	4	79	17
2015	4	115	16
2016	1	—	9
2017	1	—	38
2018	0	—	31
2019	0	—	10
2020	0	—	11
2021	0	—	18
2022	1	—	33
2023	1	—	47
2024	1	—	38
2025	1	—	34
2026	2	—	—

What is it indicated for?

The Edwards Balloon Catheter is indicated for balloon aortic valvuloplasty.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K140241 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140241: Edwards Transfemoral Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140241

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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