BD Kiestra IdentifA
Summary
Becton, Dickinson and Company received 510(k) clearance for BD Kiestra IdentifA, a QQV device. Cleared on 2023-08-31.
Details
Source
510(k) Clearance
External ID
K222563
Action Date
2023-08-31
Status
Traditional
Category
device
Product Code
QQV
Product Description
BD Kiestra IdentifA. Product code: QQV.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 413 device clearances issued this month. Becton, Dickinson and Company has received 51 total clearances in our database.
Becton, Dickinson and Company has 54 FDA actions in our database, including 3 recalls and 51 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 Becton, Dickinson and Company have FDA actions?
Becton, Dickinson and Company has 54 FDA actions in our database, including 3 recalls and 51 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K222563" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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