# K042818: Panasonic Wrist Blood Pressure Monitor, Models EW3003 and EW3037

- Pathway: 510(k) (Special)
- Applicant: Matsushita Electric Works, Ltd.
- Decided: Jan 27, 2005 after 107 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K072752: BP Limbo XL, Bptango XL, BP Salsa XL (2008), 0 descendants of its own

## Indications for use
The Panasonic Wrist Blood Pressure Monitor, Models EW 3003 and EW 3037 are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. For the EW 3037, display of Normal (green), Prehypertensive (yellow) or Hypertensive (orange) are based on blood pressure values classified in the paper: "JNC Express, The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure", U.S. Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Pressure Institute, National High Blood Pressure Education Program, NIH Publication No 03-5233, May 2003. The display values are generally known, but not proven, to be an indicator of your blood pressure. The EW 3037 is not intended to be a diagnostic device. Contact your physician if prehypertensive or hypertensive values are indicated.

Source page: https://510kreport.com/device/K042818
Methodology: https://510kreport.com/methodology