# K031195: Cuf-Cover (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Ethox Corp.
- Decided: Oct 10, 2003 after 177 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: 1 generation back to K952825 (1995). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952825: Cuff Guard, Bowen Medical Services, Inc. (1995) Summary page 1.

## Most influential descendants
- K141998: Sama Disposable Blood Pressure Cuff Barriers (2014), 1 descendant of its own
- K150227: Disposable Blood Pressure Cuff Guard (2015), 0 descendants of its own

## 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. Covers a blood pressure cuff to provide a barrier between patient and cuff.

Source page: https://510kreport.com/device/K031195
Methodology: https://510kreport.com/methodology