# K991458: Meca Wrist Blood Pressure Meter, Model EW243 and Model EW254

- Pathway: 510(k) (Traditional)
- Applicant: Matsushita Electric Corp. of America
- Decided: Apr 10, 2000 after 350 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 K942422 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942422: Panasonic Wrist Blood Pressure Meter, King & Spalding (1995) Summary page 2.

## Most influential descendants
- K033894: Panasonic Wrist Blood Pressure Monitor, Models EW 3031 and EW 3032 (2004), 0 descendants of its own

## Indications for use
Model EW243 and model EW254 are intended to be used for the oscillometric PRECISE LOGIC™ measurement of systolic and diastolic blood pressure and pulse rate using a pressurized cuff. These devices are designed for use by adults. These devices should not be used on infants or toddlers, for continuous monitoring during medical emergencies or operations, or for amy other purpose other than measuring blood pressure. Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American Nationmal Standard, Electronic or Automated Sphygmomanometers.

Source page: https://510kreport.com/device/K991458
Methodology: https://510kreport.com/methodology