FRONT-LINE Field Sterilizer (FL135)
Summary
Fort Defiance Industries, LLC received 510(k) clearance for FRONT-LINE Field Sterilizer (FL135), a FLE device. Cleared on 2025-03-07.
Details
Source
510(k) Clearance
External ID
K243801
Action Date
2025-03-07
Status
Special
Category
device
Product Code
FLE
Product Description
FRONT-LINE Field Sterilizer (FL135). Product code: FLE.
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. Fort Defiance Industries, LLC has received 2 total clearances in our database.
Fort Defiance Industries, LLC has 3 FDA actions in our database, including 1 recall 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 Fort Defiance Industries, LLC have FDA actions?
Fort Defiance Industries, LLC has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K243801" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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