# K090014: Caremate Sphygmomanometer with Stethoscope

- Pathway: 510(k) (Traditional)
- Applicant: Caremate Medical Device Co., Ltd.
- Decided: Apr 9, 2009 after 97 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: 1 generation back to K081951 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081951: Aneroid Sphygmomanometer, Model KT-A01, Wenzhou Kindcare Import & Export Co., Ltd. (2008) Summary page 2.

## Indications for use
Caremate Sphygmomanometer with Stethoscope is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (noninvasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospitals or at home to monitor both systolic and diastolic pressure by detecting Korotkoff sound. This product is only for adult use.

Source page: https://510kreport.com/device/K090014
Methodology: https://510kreport.com/methodology