# K230859: Aneroid Sphygmomanometer

- Pathway: 510(k) (Traditional)
- Applicant: Wenzhou Kangshun Medical Devices Co.,Ltd
- Decided: Jun 28, 2023 after 91 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: 7 generations back to K790810 (1979). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212416: WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203, Wenzhou Xikang Medical Instruments Co., Ltd. (2022) Summary page 4.

## Indications for use
The aneroid sphygmomanometer is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on children or adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. There are a variety of stethoscopes can be an optioned accessory,depending on the model.

Source page: https://510kreport.com/device/K230859
Methodology: https://510kreport.com/methodology