# K120125: Soft-Cuf, Classic-Cuf, Dura-Cuf, Sensa-Cuf

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies, Inc.
- Decided: Oct 3, 2012 after 260 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: 2 generations back to K790810 (1979). 7 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974080: Critikon Soft Blood Pressure Cuff, Johnson & Johnson Medical, Inc. (1998) Summary page 1.
- K022482: Sensa-Cuff, Models Infant, Child, Adult, Ge Medical Systems Information Technologies (2002) Summary page 1.

## Most influential descendants
- K260747: YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff (2026), 0 descendants of its own
- K230145: One-Cuf (2023), 0 descendants of its own
- K123996: Radial-Cuf Non-Invasive Blood Pressure Cuff (2013), 0 descendants of its own

## Indications for use
GE CRITIKON blood pressure cuffs are accessories used in conjunction with noninvasive blood pressure (NIBP) measurement systems. SOFT-CUF and CLASSIC-CUF cuffs and inflation systems are non-sterile and limited reuse (may be single-patient use or optional limited reuse). They are available in neonatal, pediatric and adult sizes. DURA-CUE and SENSA-CUF cuffs and inflation systems are non-sterile and may be reused. They are available in pediatric and adult sizes. The devices are not designed, sold or intended for use except as indicated.

Source page: https://510kreport.com/device/K120125
Methodology: https://510kreport.com/methodology