# K043444: Multiple, Model KTJ-50

- Pathway: 510(k) (Traditional)
- Applicant: Golden Horse Medical Equipment (Wuxi) Co., Ltd.
- Decided: Feb 22, 2005 after 70 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 K942072 (1995). 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)
- K942072: Mabis Brand and Mabis Customers Private Label Brand, Mabis Healthcare, Inc. (1995) Summary page 1.

## Indications for use
The Multiple Brand, with model number KTJ-50, aneroid sphygmomanometer is an instrument intended to be used for the indirect (noninvasive) measurement of huaan's Systolic, Diastolic blood pressure using the auscultatory method by detecting Korotkoff Sound. This device is to be used by bained medical and healtb care personnel or trained general users.

Source page: https://510kreport.com/device/K043444
Methodology: https://510kreport.com/methodology