# K110501: HEM-4030

- Pathway: 510(k) (Special)
- Applicant: Omron Healthcare, Inc.
- Decided: Mar 21, 2011 after 27 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: 1 generation back to K903133 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903133: Omron Oscillometric Digital BP Monitor-Hem-405C, Omron Marshall Products, Inc. (1991) Summary page 1.

## Indications for use
The HEM-4030 is a digital monitor intended for measuring systolic and diastolic blood pressure and pulse rate in adults. The Omron HEM-4030 is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Source page: https://510kreport.com/device/K110501
Methodology: https://510kreport.com/methodology