# K041689: Polyurethane Blood Pressure Cuffs

- Pathway: 510(k) (Special)
- Applicant: D. E. Hokanson, Inc.
- Decided: Aug 6, 2004 after 45 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
Hokanson Digit and Penile cuffs are intended to measure blood pressure in small peripheral body parts or small infants. For accuracy, the width of a blood pressure cuff should be approximately the same as the diameter of the limb or digit being measured. The length of the cuff, in the case of these devices, is long enough to completely encircle the object being measured. The usage is the same as the predicate device which has been manufactured by our company since 1973.

Source page: https://510kreport.com/device/K041689
Methodology: https://510kreport.com/methodology