# K231961: NIBPCuff

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Sino-K Medical Technology Co.,Ltd
- Decided: Aug 30, 2023 after 58 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: 4 generations back to K790810 (1979). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182433: Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff, Shenzhen Caremed Medical Technology Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K250765: AViTA Arm Type Blood Pressure Monitor Cuff (2025), 0 descendants of its own

## Indications for use
The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

Source page: https://510kreport.com/device/K231961
Methodology: https://510kreport.com/methodology