# K041778: Reizen Talking Blood Pressure Monitor, Model #SF860T

- Pathway: 510(k) (Abbreviated)
- Applicant: Maxi-Aids, Inc.
- Decided: Aug 31, 2004 after 61 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) A&D Medical LifeSource Talking Digital Blood Pressure Monitor, Model UA-767TI: named in the summary without a submission number

## Most influential descendants
- K111652: Microlife Automatic Talking Blood Pressure Monitor (2011), 4 descendants of its own
- K131346: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2013), 3 descendants of its own
- K172880: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2018), 2 descendants of its own
- K183469: Microlife Digital Blood Pressure Monitor (2019), 1 descendant of its own
- K190818: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2019), 0 descendants of its own

## Indications for use
The device measures systolic and diastolic blood pressures and pulse rate. It uses the oscillometric method. It is indicated for use by adults (those 18 years of age and older) at home or in an outpatient setting.

Source page: https://510kreport.com/device/K041778
Methodology: https://510kreport.com/methodology