510(k) · Cleared
ClearedMullins-X PTV Catheter
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 Dec 9, 2010 as substantially equivalent to K022722 (NuMED, Inc., 2002) after a 101-day review. Its family tree reaches back 1 generation to 2002. 6 later devices descend from it.
- Decided
- Dec 9, 2010
- Review
- 101 days
- Class
- Class II
- Product code
- OMZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022722 (2002). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK022722 Pta and PTVNuMED, Inc. · 2002
- This deviceK102473 Mullins-X PTV CatheterNuMED, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK122367 Bard PTV Dilatation CatheterC.R. Bard, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK131002 Vida PTV Dilataton CatheterC.R. Bard, Inc. · 2013
- Descendant · 3 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 · 4 generations on · 1 of its ownK241040 Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K122367Bard PTV Dilatation CatheterC.R. Bard, Inc. · 2012 · cites it directly5descendants
- K131002Vida PTV Dilataton CatheterC.R. Bard, Inc. · 2013 · 2 generations on4descendants
- K141985True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc. · 2014 · 3 generations on3descendants
- K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV…C.R. Bard, Inc. · 2022 · 3 generations on2descendants
- K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022722 | Pta and PTV | NuMED, Inc. | 2002 | — |
| 0 (this device) | K102473 | Mullins-X PTV Catheter | NuMED, Inc. | 2010 | — |
| +1 | K122367 | Bard PTV Dilatation Catheter | C.R. Bard, Inc. | 2012 | — |
| +2 | K131002 | Vida PTV Dilataton Catheter | C.R. Bard, Inc. | 2013 | — |
| +3 | 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 | — |
| +4 | K241040 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022722 | Pta and PTVSummary page 1…Trade Name: Mullins-X PTV Catheter Provisions Classification Name: Catheter, Percutaneous (Valvuloplasty) Name of Z-MED-X PTV Catheter - K022722 Predicate Device Classification Class 11, 21 CFR 870,1250 -Product Code OMZ Performance Performance Standards have not… | 2002 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122367 | Bard PTV Dilatation Catheter | 2012 | 5 |
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?
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. 2010, this device’s year, is highlighted.
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?
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.
This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102473 · printed Nov 3, 2026
Cite this page
510(k) Report. “K102473: Mullins-X PTV Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102473
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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