PIVO Pro Needle-free Blood Collection Device
Summary
Becton Dickinson Infusion Therapy Systems, Inc. received 510(k) clearance for PIVO Pro Needle-free Blood Collection Device, a JKA device. Cleared on 2025-02-27.
Details
Source
510(k) Clearance
External ID
K241586
Action Date
2025-02-27
Status
Traditional
Category
device
Product Code
JKA
Product Description
PIVO Pro Needle-free Blood Collection Device. Product code: JKA.
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. Becton Dickinson Infusion Therapy Systems, Inc. has received 10 total clearances in our database.
Becton Dickinson Infusion Therapy Systems, Inc. has 25 FDA actions in our database, including 15 recalls and 10 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 Infusion Therapy Systems, Inc. have FDA actions?
Becton Dickinson Infusion Therapy Systems, Inc. has 25 FDA actions in our database, including 15 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K241586" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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