Promisemed Heel Blood Lancet
Summary
Promisemed Hangzhou Meditech Co., Ltd. received 510(k) clearance for Promisemed Heel Blood Lancet, a FMK device. Cleared on 2022-06-08.
Details
Source
510(k) Clearance
External ID
K221371
Action Date
2022-06-08
Status
Special
Category
device
Product Code
FMK
Product Description
Promisemed Heel Blood Lancet. Product code: FMK.
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. Promisemed Hangzhou Meditech Co., Ltd. has received 25 total clearances in our database.
Promisemed Hangzhou Meditech Co., Ltd. has 25 FDA actions in our database, including 25 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 Promisemed Hangzhou Meditech Co., Ltd. have FDA actions?
Promisemed Hangzhou Meditech Co., Ltd. has 25 FDA actions in our database, including 0 recalls and 25 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K221371" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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