# K193629: Disposable NIBP Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Changke Connect Electronics Co., Ltd.
- Decided: Mar 25, 2020 after 90 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.
No later device cites it as a predicate yet.
0 of 11 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.

## Indications for use
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/K193629
Methodology: https://510kreport.com/methodology