# K031416: Clearmedical/Critikon Blood Pressure Cuff; Clearmedical/Welch Allyn Blood Pressure Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Clearmedical, Inc.
- Decided: Jul 15, 2003 after 71 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. The FDA summary names no predicate by number.

## Indications for use
The ClearMedical Blood Pressure Cuff is indicated for use in manual measurement and automatic non-invasive blood pressure (BP) monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual BP measurement The ClearMedical Blood Pressure Cuff is intended as a single patient use item.

Source page: https://510kreport.com/device/K031416
Methodology: https://510kreport.com/methodology