Summary
Keystone Industries received 510(k) clearance for FP3D, a EBI device. Cleared on 2025-05-20.
Details
Source
510(k) Clearance
External ID
K250489
Action Date
2025-05-20
Status
Traditional
Category
device
Product Code
EBI
Product Description
FP3D. Product code: EBI.
Company
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. Keystone Industries has received 2 total clearances in our database.
Keystone Industries has 25 FDA actions in our database, including 23 recalls and 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 Keystone Industries have FDA actions?
Keystone Industries has 25 FDA actions in our database, including 23 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K250489" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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