Medical device cleared or certified
device.certified · Ready US medical device clearances and approvals, US
What it is
Public: from open or licensed sources, shared by everyone who subscribes.
- Example: FDA cleared Corvana Pulse Oximeter P2 from Corvana Medical, Inc. (510(k) K261234)
- Typed payload, validated by its JSON Schema
- Collected today from US medical device clearances and approvals (US)
Each event names its exact source, a link to the record, the licence and the attribution in its provenance.
Example event, standard format
{
"specversion": "1.0",
"id": "evt_01M5EV0NM0DPGYNY5TQ23JPBV5",
"type": "device.certified",
"source": "/sources/examples/device",
"time": "2026-10-21T09:00:00Z",
"observed_at": "2026-10-21T09:00:42Z",
"dataschema": "https://schemas.worldsignals.dev/device.certified/1.json",
"datacontenttype": "application/json",
"visibility": "public",
"country": "US",
"region": "US-MN",
"subject": {
"kind": "product",
"name": "Corvana Pulse Oximeter P2",
"ids": {
"us_fda_k_number": "K261234"
},
"ws_id": "ent_01M5EV0NM095F9VJJC674KX6AK"
},
"entities": [
{
"kind": "company",
"role": "applicant",
"name": "Corvana Medical, Inc."
}
],
"title": "FDA cleared Corvana Pulse Oximeter P2 from Corvana Medical, Inc. (510(k) K261234)",
"data": {
"authority": "FDA",
"pathway": "510k",
"decision": "cleared",
"decision_on": "2026-10-09",
"received_on": "2026-06-30",
"reference_number": "K261234",
"decision_code": "SESE",
"clearance_type": "traditional",
"product_code": "DQA",
"device_type": "Oximeter",
"regulation_number": "870.2700",
"device_class": "2",
"panel": "Cardiovascular",
"applicant_country": "US",
"applicant_region": "US-MN",
"time_precision": "day"
},
"provenance": {
"source_id": "example",
"source_name": "Example data",
"url": "https://example.com/worldsignals/device.certified",
"licence": "Example only, not a real record",
"method": "example"
},
"confidence": 0.95,
"personal_data": false,
"revision": 1,
"tags": [
"example"
]
}Give your agents something to notice
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