# K894563: Omron Digital Blood Pressure Monitor Model HEM814F

- Pathway: 510(k) (Traditional)
- Applicant: Omron Electronics, Inc.
- Decided: Mar 6, 1990 after 228 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K081924: Calhealth, Inc., Finger Blood Pressure Monitor, Mdmouse (2009), 1 descendant of its own
- K261061: BP Go (BPP-855) (2026), 0 descendants of its own
- K954547: CH-502A & CH520B Digital Finger Sphygmomanometer (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K894563
Methodology: https://510kreport.com/methodology