# K222652: Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer

- Pathway: 510(k) (Traditional)
- Applicant: Cardicare Company, Ltd.
- Decided: Nov 28, 2022 after 88 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: 8 generations back to K790810 (1979). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082542: Aneroid Sphygmomanometer with Stethoscope Model HBPK-a, Cardicare Company, Ltd. (2008) Summary page 4.
- K211084: Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope, Shanghai Caremate Medical Device Co., Ltd. (2021) Summary page 4.

## Indications for use
The Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and adults. The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds. The Single Patient Use Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and adults. The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds.

Source page: https://510kreport.com/device/K222652
Methodology: https://510kreport.com/methodology