510(k) · Cleared

Recalled · Class II · 2013

True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20MM X 4.5CM, True Dilatation Percutaneous Translumina

K121083510(k) TraditionalCleared Oct 11, 2012184-day reviewClass II21 CFR 870.1255Recalls 1

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

Loma Vista Medical · OZT Balloon Aortic Valvuloplasty

Cleared on Oct 11, 2012 after a 184-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 13 later devices descend from it. It has been recalled once.

Decided: Oct 11, 2012
Review: 184 days
Class: Class II
Product code: OZT
Recalls: 1
Predicates: 1

13 later devices descend from it, 3 citing it directly.

This deviceK121083 True Dilatation Percutaneous Transluminal Valvuloplasty Catheter…Loma Vista Medical · 2012
Descendant · cites it directly · 9 of its ownK133569 True Dilatation Balloon Valvuloplasty Catheter, 20MM X 4.5 CM, 22MM…Bard Peripheral Vascular, Inc. · 2013
Descendant · 2 generations on · 3 of its ownK142083 True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc. · 2015
Descendant · 2 generations on · 3 of its ownK141985 True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc. · 2014
Descendant · 3 generations on · 2 of its ownK212588 Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation…C.R. Bard, Inc. · 2022
Descendant · 3 generations on · 2 of its ownK152613 True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc. · 2016

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2013high 3 (2014) · low 0 (2018)2026

Most influential descendants

Showing 5 of 13 · See all

K133569True Dilatation Balloon Valvuloplasty Catheter, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X…Bard Peripheral Vascular, Inc. · 2013 · cites it directly9descendants
K142083True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc. · 2015 · 2 generations on3descendants
K141985True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc. · 2014 · 2 generations on3descendants
K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV…C.R. Bard, Inc. · 2022 · 3 generations on2descendants
K152613True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc. · 2016 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K121083	True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20MM X…	Loma Vista Medical	2012	—
+1	K133569	True Dilatation Balloon Valvuloplasty Catheter, 20MM X 4.5 CM, 22MM X 4.5CM…	Bard Peripheral Vascular, Inc.	2013	—
+2	K142083	True Flow Valvuloplasty Perfusion Catheter	C.R. Bard, Inc.	2015	—
+2	K141985	True BA V Balloon Valvuloplasty Catheter	C.R. Bard, Inc.	2014	—
+3	K212588	Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida…	C.R. Bard, Inc.	2022	—
+3	K152613	True Flow Valvuloplasty Perfusion Catheter	C.R. Bard, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	3	0
2015	2	0
2016	1	0
2017	1	0
2022	1	0
2023	1	0
2024	1	0
2025	2	0

FIG. 1 — Lineage of K121083, 2012–2025Source: 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

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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; 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	K082776	NuCLEUS Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1 …CFR 870.1255 Product Code: OZT Predicate Device(s): The subject device is equivalent to the following devices: NuCLEUS, 5 10(k) number K082776 Device Description: The Loma Vista Medical (LVM) TRUE DilatationTM Catheter is a coaxial catheter with…

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K133569	True Dilatation Balloon Valvuloplasty Catheter, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X…	Bard Peripheral Vascular, Inc.	2013	9
K140241	Edwards Transfemoral Balloon Catheter	Edwards Lifesciences, LLC	2014	1
K142199	Ascendra Balloon Aortic Valvaloplasty Catheter	Edwards Lifesciences	2014	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 18, 2013	Class II	Z-1566-2013	Process design	Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specification for deflation time is 10 seconds maximum.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K133569 (Bard Peripheral Vascular, Inc., 2013) has gone furthest, with 9 descendants of its own.

How does its category compare?

All OZT devices

OZT Balloon Aortic Valvuloplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 TRUE Dilatation Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121083 · printed Nov 5, 2026

Cite this page

510(k) Report. “K121083: True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20MM X 4.5CM, True Dilatation Percutaneous Translumina.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121083

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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