# K122012: Z-Med Z-Med II

- Pathway: 510(k) (Traditional)
- Applicant: NuMED, Inc.
- Decided: Oct 4, 2012 after 86 days
- Product code: OZT (Balloon Aortic Valvuloplasty)
- Device class: 2
- Regulation: 21 CFR 870.1255
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but 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.

## Most influential descendants
- K150343: V8 Transluminal BAV Catheter (2015), 1 descendant of its own
- K140241: Edwards Transfemoral Balloon Catheter (2014), 1 descendant of its own
- K253855: KardiaPSI Balloon Catheter (2026), 0 descendants of its own
- K231814: ValvuloPro Valvuloplasty Balloon Catheter (2023), 0 descendants of its own
- K152150: V8 Balloon Aortic Valvuloplasty Catheter (2015), 0 descendants of its own

## Indications for use
Balloon Aortic Valvuloplasty

Source page: https://510kreport.com/device/K122012
Methodology: https://510kreport.com/methodology