# K122443: Ufit Ten-10

- Pathway: 510(k) (Abbreviated)
- Applicant: Biosign Technologies, Inc.
- Decided: Nov 20, 2012 after 102 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- 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 K001670 (2000). 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)
- K102939: Fully Automatic Electronic Blood Pressure Monitor Model KD-931, Andon Health Co, Ltd. (2011)
- K103046: Hosman Usb Blood Pressure Monitor; Wrist Type and Upper Arm Type, Hosman International Co., Ltd. (2011) Summary page 1.

## Indications for use
The UFITS TEN-l0 Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services is a non-invasive blood pressure measurement system intended to measure the systolic and diastolic blood pressure and pulse rate. It is intended for patient Use at home and by healthcare professionals in their respective practice. The device is intended for use by adults 18 years or older. The cuff is to be used for wrist sizes from 13.5 cm to 23 cm (5.3 in to 9.1 in).

Source page: https://510kreport.com/device/K122443
Methodology: https://510kreport.com/methodology