# K211084: Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Caremate Medical Device Co., Ltd.
- Decided: Oct 19, 2021 after 190 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.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192500: Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer, Honsun (Nantong) Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K240165: Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer (2024), 0 descendants of its own
- K222652: Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer (2022), 0 descendants of its own

## Indications for use
The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new horns, infants, children, young adults 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/K211084
Methodology: https://510kreport.com/methodology