# K061935: Sensacare Saw-102 Wrist Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Sensacare, Ltd.
- Decided: Nov 8, 2006 after 121 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: 2 generations back to K002115 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040229: A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328, A&D Engineering, Inc. (2004) Summary page 2.

## Indications for use
The SensaCare SAW-102 Wrist Digital Blood Pressure Monitor is a hand held battery operated wrist type blood pressure monitor which is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. The measurement is by the oscillometric method wherein a cuff is placed on the limb and the pressure in the cuff is increased until the blood flow in the artery is interrupted and then the pressure in the cuff is slowly reduced. The measurement result is shown on a LCD panel in the monitor. The measuring ranges are (1) systolic pressure: 30 to 280 mrfilg (2) diastolic pressure: 20 to 255 mmHg (3) heart rate: 20 to 255 times/minutes.

Source page: https://510kreport.com/device/K061935
Methodology: https://510kreport.com/methodology