# K230145: One-Cuf

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies, Inc.
- Decided: Mar 14, 2023 after 55 days
- Product code: DXQ (Blood Pressure Cuff)
- Device class: 2
- Regulation: 21 CFR 870.1120
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K790810 (1979). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120125: Soft-Cuf, Classic-Cuf, Dura-Cuf, Sensa-Cuf, Ge Medical Systems Information Technologies, Inc. (2012) Summary page 4.

## Recalls of this device
- Apr 9, 2024 · Class II · Z-2027-2024: Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.

## Indications for use
The blood pressure cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. It is non-sterile, single-patient use. It is available in pediatric and adult sizes. The cuff is not designed, sold or intended for use except as indicated.

Source page: https://510kreport.com/device/K230145
Methodology: https://510kreport.com/methodology