# K082630: Vitalcheck Blood Pressure Cuff, Model ZVC4000 Series

- Pathway: 510(k) (Abbreviated)
- Applicant: Zefon Intl.
- Decided: Dec 19, 2008 after 100 days
- Product code: DXQ (Blood Pressure Cuff)
- Device class: 2
- Regulation: 21 CFR 870.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Zefon NIPB blood pressure cuffs, tubing & adapters are reusable accessories used in conjunction with non-invasive automatic blood pressure monitors or non-invasive manual blood pressure measurement systems.

Source page: https://510kreport.com/device/K082630
Methodology: https://510kreport.com/methodology