510(k) Report

FDA product code · Cardiovascular

Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

OMZClass II21 CFR 870.1250510(k) required5 decisions since 20020 recalls

5 FDA decisions since 2002. No recall names this code. The most-cited predicate is K131002, named by 2 later devices.

Catheter is used for Percutaneous Transluminal or balloon Valvuloplasty (PTV) of the pulmonary (pulmonic) valve. Used on patients with isolated pulmonary stenosis and also on patients with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

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

FIG. A — Illustration, cardiovascular panel

Twenty years of OMZ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OMZ

1in 2016

2010: 12012: 12013: 12016: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OMZ

Too few OMZ 510(k)s in any year since 2007 to give a median.

Recalls per year · OMZ

No recall names OMZ since 2007.

Adverse event reports per year · OMZ

3in 2024

2013: 12014: 12015: 32016: 22018: 12019: 42021: 52023: 12024: 3
2007high 5 (2021) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—00
20110—00
20121—00
20131—01
20140—01
20150—03
20161—02
20170—00
20180—01
20190—04
20200—00
20210—05
20220—00
20230—01
20240—03
20250—00
20260—0—
FIG. 1 — OMZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OMZ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do OMZ devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K131002Vida PTV Dilataton CatheterC.R. Bard, Inc. · 20132cite it
  • K102473Mullins-X PTV CatheterNuMED, Inc. · 20101cites it
  • K014124Numed Coefficient PTV CathetersNuMED, Inc. · 20021cites it
  • K122367Bard PTV Dilatation CatheterC.R. Bard, Inc. · 20121cites it

Which OMZ devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K131002Vida PTV Dilataton CatheterC.R. Bard, Inc. · 20136generations
  • K122367Bard PTV Dilatation CatheterC.R. Bard, Inc. · 20125generations
  • K153069Edwards Balloon CatheterEdwards Lifesciences · 20163generations
  • K102473Mullins-X PTV CatheterNuMED, Inc. · 20101generation

What has FDA decided in OMZ lately?

  • K153069Edwards Balloon CatheterEdwards Lifesciences · 2016
  • K131002Vida PTV Dilataton CatheterC.R. Bard, Inc. · 2013
  • K122367Bard PTV Dilatation CatheterC.R. Bard, Inc. · 2012
  • K102473Mullins-X PTV CatheterNuMED, Inc. · 2010
  • K014124Numed Coefficient PTV CathetersNuMED, Inc. · 2002

All 5 OMZ decisions →

Related product codes

Other codes under 21 CFR 870.1250.

NTE Temporary Carotid Catheter For Embolic CaptureOFK Percutaneous Atrial Catheter KitDQY Catheter, PercutaneousPNO Catheter, Percutaneous, Cutting/ScoringPDU Catheter For Crossing Total OcclusionsNFA Temporary Coronary Saphenous Vein Bypass Graft…PPN Percutaneous Catheter, UltrasoundNMM Catheter, Angioplasty, Peripheral…NRY Catheter, Thrombus RetrieverNVM Catheter, Angioplasty, Peripheral…LIT Catheter, Angioplasty, Peripheral, TransluminalQJP Catheter, Percutaneous, Neurovasculature