Under Review
v1.0.4-LATEST
Predicate Device
Architectural Definition
A legally marketed device to which a new device is compared in a 510(k) submission.
Schema Preview
● application/json
{
"entity": "predicate-device",
"domain": "pharmacy",
"metadata": {
"displayName": "Predicate Device",
"status": "DRAFT",
"version": "1.0.4",
"isStandardized": false
}
}Standard
ISO-8601
Data Type
String/Obj
Steward
Arch Council
Verified
Feb 2026