WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201,
Summary
Wenzhou Xikang Medical Instruments Co., Ltd. received 510(k) clearance for WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203, a DXQ device. Cleared on 2022-05-18.
Details
Source
510(k) Clearance
External ID
K212416
Action Date
2022-05-18
Status
Traditional
Category
device
Product Code
DXQ
Product Description
WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203. Product code: DXQ.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Wenzhou Xikang Medical Instruments Co., Ltd. has received 2 total clearances in our database.
Wenzhou Xikang Medical Instruments Co., Ltd. has 2 FDA actions in our database, including 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Wenzhou Xikang Medical Instruments Co., Ltd. have FDA actions?
Wenzhou Xikang Medical Instruments Co., Ltd. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K212416" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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