Meca Wrist Blood Pressure Meter, Model EW243 and Model EW254
by Matsushita Electric Corp. of America
510(k) K991458
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991458 | Date10 Apr 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Meca Wrist Blood Pressure Meter, Models EW243 and EW254, is an oscillometric device designed for non-invasive measurement of systolic and diastolic blood pressure and pulse rate in adults. It utilises a wrist-worn cuff to inflate and monitor arterial pressure oscillations, providing automated readings for clinical or home monitoring purposes.
These meters are intended for single-use or reusable application in clinical or home settings, as specified by the manufacturer. They are classified under FDA product code DXN as Class II devices with Special Controls and hold an FDA 510(k) clearance (K991458) for substantial equivalence. No additional regulatory markings regarding sterility, MRI safety, or storage conditions are provided in the available data.
Questions
AI-generated answers, 19 Sep 2026
What types of blood pressure readings does the Meca Wrist Blood Pressure Meter provide, and how are they measured?
The Meca Wrist Blood Pressure Meter (Models EW243 and EW254) measures systolic and diastolic blood pressure, as well as pulse rate, using an oscillometric method. This involves inflating a wrist-worn cuff to temporarily restrict blood flow and then detecting arterial pressure oscillations to calculate the readings automatically. It is designed for both clinical and home monitoring of adults.
Are the Meca Wrist Blood Pressure Meters intended for single-use or reusable applications, and how should they be handled?
The device is intended for either single-use or reusable application, depending on the clinical or home setting’s protocol. Since no sterility or reprocessing instructions are specified in the data, users should follow manufacturer guidelines (e.g., cleaning, disinfection, or disposal) to ensure proper hygiene if reused. Always refer to the included instructions for use to confirm handling requirements.
What regulatory pathway was followed for FDA clearance of these devices, and what does that mean for users?
The Meca Wrist Blood Pressure Meter (Models EW243 and EW254) received FDA 510(k) clearance (K991458) under the Traditional 510(k) pathway, demonstrating substantial equivalence to a legally marketed predicate device. This means the device meets FDA’s Class II Special Controls for non-invasive blood pressure monitors (product code DXN) and has undergone review by the Cardiovascular (CV) Advisory Committee. Users can rely on this clearance as evidence of compliance with applicable safety and performance standards.
What are the key differences between Model EW243 and Model EW254, and how might that affect my choice?
The provided data does not specify functional or technical differences between the EW243 and EW254 models beyond their classification as wrist blood pressure meters. To determine which model best fits your needs—such as features, accuracy, or intended use—you should consult the manufacturer’s documentation or contact Matsushita Electric Corp. of America directly, as the data does not detail variations in specifications, software, or additional capabilities.