Under Review
v1.0.4-LATEST
510(k) Clearance
Architectural Definition
A premarket submission made to the FDA to demonstrate that a device is at least as safe and effective as a legally marketed device.
Schema Preview
● application/json
{
"entity": "510-k-clearance",
"domain": "pharmacy",
"metadata": {
"displayName": "510(k) Clearance",
"status": "DRAFT",
"version": "1.0.4",
"isStandardized": false
}
}Standard
ISO-8601
Data Type
String/Obj
Steward
Arch Council
Verified
Feb 2026