510(k) · Cleared
ClearedZ-Med Z-Med II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
NuMED, Inc. · OZT Balloon Aortic Valvuloplasty
Cleared on Oct 4, 2012 after an 86-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 6 later devices descend from it.
- Decided
- Oct 4, 2012
- Review
- 86 days
- Class
- Class II
- Product code
- OZT
- Recalls
- None
- Predicates
- 1
6 later devices descend from it, 4 citing it directly.
- This deviceK122012 Z-Med Z-Med IINuMED, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK150343 V8 Transluminal BAV CatheterIntervalve, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK140241 Edwards Transfemoral Balloon CatheterEdwards Lifesciences, LLC · 2014
- Descendant · cites it directly · 0 of its ownK253855 KardiaPSI Balloon CatheterIntervention Tech, Inc. ; dba Corvention · 2026
- Descendant · 2 generations on · 0 of its ownK231814 ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK152150 V8 Balloon Aortic Valvuloplasty CatheterIntervalve, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K150343V8 Transluminal BAV CatheterIntervalve, Inc. · 2015 · cites it directly1descendant
- K140241Edwards Transfemoral Balloon CatheterEdwards Lifesciences, LLC · 2014 · cites it directly1descendant
- K253855KardiaPSI Balloon CatheterIntervention Tech, Inc. ; dba Corvention · 2026 · cites it directly0descendants
- K231814ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc. · 2023 · 2 generations on0descendants
- K152150V8 Balloon Aortic Valvuloplasty CatheterIntervalve, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K122012 | Z-Med Z-Med II | NuMED, Inc. | 2012 | — |
| +1 | K150343 | V8 Transluminal BAV Catheter | Intervalve, Inc. | 2015 | — |
| +1 | K140241 | Edwards Transfemoral Balloon Catheter | Edwards Lifesciences, LLC | 2014 | — |
| +1 | K253855 | KardiaPSI Balloon Catheter | Intervention Tech, Inc. ; dba Corvention | 2026 | — |
| +2 | K231814 | ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, Inc. | 2023 | — |
| +2 | K152150 | V8 Balloon Aortic Valvuloplasty Catheter | Intervalve, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 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
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 | Decided |
|---|---|---|---|
| Kept off the family tree | K082776 | NuCLEUS-X Catheter 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…: Z-MED and Z-MED 11 Catheters Provisions Classification Name: Balloon Aortic Valvuloplasty Catheters Name of NuCLEUS-X Catheter (K082776) Predicate NuCLEUS Catheter (K082776) Device Classification Class 11, 21 CFR 870.1255 Performance… |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K150343 (Intervalve, Inc., 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OZT devicesOZT 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
2026 to Oct 25, outlined.
Median 510(k) review, days · OZT
115in 2015
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 3 | — | 0 | 0 |
| 2013 | 3 | 80 | 0 | 29 |
| 2014 | 4 | 79 | 0 | 17 |
| 2015 | 4 | 115 | 0 | 16 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 1 | — | 0 | 38 |
| 2018 | 0 | — | 0 | 31 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 18 |
| 2022 | 1 | — | 0 | 33 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 1 | — | 0 | 38 |
| 2025 | 1 | — | 0 | 34 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Balloon Aortic Valvuloplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122012 · printed Nov 3, 2026
Cite this page
510(k) Report. “K122012: Z-Med Z-Med II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K122012
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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