# K903133: Omron Oscillometric Digital BP Monitor-Hem-405C

- Pathway: 510(k) (Traditional)
- Applicant: Omron Marshall Products, Inc.
- Decided: Jan 18, 1991 after 185 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
- K970139: Microlife Manual Blood Pressure Monitor  (Manual Inflate) Model BP-2BIO (1998), 1 descendant of its own
- K110501: HEM-4030 (2011), 0 descendants of its own
- K073397: Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (BP A50) (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K903133
Methodology: https://510kreport.com/methodology