# K032568: BP Cuff Barrier 1081789, BP Cuff Barrier, Plastic Coated 1030193

- Pathway: 510(k) (Traditional)
- Applicant: Med Textile, LLC
- Decided: Apr 29, 2004 after 253 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
The BP Cuff Barrier is a disposable non-sterile device with a medical purpose, worn by the patient as a barrier to prevent contamination between patient and blood pressure cuff.

Source page: https://510kreport.com/device/K032568
Methodology: https://510kreport.com/methodology