# K150227: Disposable Blood Pressure Cuff Guard

- Pathway: 510(k) (Traditional)
- Applicant: Pinhu Sama Medical Packing Co., Ltd.
- Decided: Apr 2, 2015 after 59 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
Longest line of descent: 3 generations back to K952825 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141998: Sama Disposable Blood Pressure Cuff Barriers, Pinghu Sama Medical Packing Co., Ltd. (2014) Summary page 6.

## Indications for use
This device has the potential to reduce or prevent patient to patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. It covers a blood pressure cuff to provide a barrier between patient and cuff.

Source page: https://510kreport.com/device/K150227
Methodology: https://510kreport.com/methodology