# K123996: Radial-Cuf Non-Invasive Blood Pressure Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies, Inc.
- Decided: Apr 9, 2013 after 104 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 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 1.

## Indications for use
GE CRITIKON blood pressure cuffs are accessories used in conjunction with noninvasive blood pressure (NIBP) measurement systems. The RADIAL-CUF is intended for use with automated oscillometric NIBP devices to measure radial arterial pressure on the forearm. The RADIAL-CUF is available in adult size only. The device is non-sterile and is semi-disposable (may be single-patient use or optional limited reuse). The cuff is intended for use in patients whose upper arm circumference is greater than 40cm or in patients where currently marketed GE CRITIKON upper arm cuffs cannot be used, due to excess width of the cuff or conical shape of the upper arm. The forearm cuff is intended to be placed on the patient's forearm with circumference ranging from 26cm -36cm. The devices are not designed, sold or intended for use except as indicated.

Source page: https://510kreport.com/device/K123996
Methodology: https://510kreport.com/methodology