# K021239: Eikon Automatic Digital Blood Pressure Monitor, Model HD-400M

- Pathway: 510(k) (Traditional)
- Applicant: Eikon Healthcare Device Corp.
- Decided: Nov 8, 2002 after 204 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.
19 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040159: Apm Blood Pressure Monitor, Model BP108A (2004), 17 descendants of its own
- K051703: Clever TD-3018A Blood Pressure Monitor (2005), 8 descendants of its own
- K042795: Clever Chek TD-3213 (2005), 6 descendants of its own
- K051907: Innocor (2006), 4 descendants of its own
- K071911: Cardiopulmonary Exercise Testing Option to Innocor (2007), 3 descendants of its own

## Indications for use
The EIKON automatic digital blood pressure monitor, Model HD-400MY is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3” - 8.5%.

Source page: https://510kreport.com/device/K021239
Methodology: https://510kreport.com/methodology