510(k) · Cleared
ClearedNumed Coefficient PTV Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
NuMED, Inc. · OMZ Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
Cleared on Jan 16, 2002 after a 30-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Jan 16, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- OMZ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K014124 | Numed Coefficient PTV Catheters | NuMED, Inc. | 2002 | — |
| +1 | K040830 | Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters | NuMED, Inc. | 2004 | — |
| +2 | K153069 | Edwards Balloon Catheter | Edwards Lifesciences | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2016 | 1 | 0 |
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 OMZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040830 | Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters | 2004 | 1 |
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?
- Of its descendants, K040830 (NuMED, Inc., 2004) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OMZ devicesOMZ Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OMZ
1in 2016
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
MAUDE reports naming product code OMZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This catheter is recommended for Percutaneous Transluminal Valvuloplasty
(PTV) of the pulmonary valve.
= A patient with isolated pulmonary stenosis
= A patient with valvular pulmonary stenosis with other minor congenital
heart disease that does not require surgical intervention.
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/K014124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014124: Numed Coefficient PTV Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014124
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026