FDA 510(k) Medical Device Clearances

Search the FDA 510(k) premarket notification database for medical device clearances and approvals. This actor uses the official OpenFDA API -- no API key required.

Use Cases

• Medical device companies -- Monitor competitor device clearances, track new entrants in your product category, and identify predicate devices for your own 510(k) submissions.
• Healthcare investors -- Screen for newly cleared devices by company or product category. Identify companies with active FDA pipelines and track approval timelines.
• Regulatory consultants -- Research clearance history for specific device types, find predicate devices, and analyze decision patterns by product code or advisory committee.
• Competitor intelligence -- Track which companies are getting clearances in your space, how quickly decisions are made, and what device names are entering the market.
• Supply chain and procurement -- Identify cleared medical device suppliers by location, product code, or device category.

Input Parameters

Parameter	Description	Example
Device Name	Search by device name	stent, catheter, implant
Applicant	Search by company name	medtronic, boston scientific
Product Code	Search by FDA product code	DZE, NIQ
Date From	Start of decision date range (YYYY-MM-DD)	2024-01-01
Date To	End of decision date range (YYYY-MM-DD)	2024-12-31
Max Results	Maximum results to return (1-10000)	100

At least one of Device Name, Applicant, or Product Code is required.

Output Fields

Each result includes:

• kNumber -- The 510(k) submission number (e.g. K241234)
• deviceName -- Name of the device
• applicant -- Company that submitted the application
• decisionDate -- Date the FDA made its decision
• decisionCode -- Decision code (SESE = Substantially Equivalent, SESD = Substantially Equivalent with limitations, etc.)
• decisionDescription -- Human-readable decision description
• productCode -- FDA product classification code
• advisoryCommittee -- FDA advisory committee that reviewed the device
• clearanceType -- Type of clearance
• city, state, countryCode -- Applicant location
• statementOrSummary -- Whether a summary or statement was provided

Example

Search for stent clearances in 2024:

{
    "deviceName": "stent",
    "dateFrom": "2024-01-01",
    "dateTo": "2024-12-31",
    "maxResults": 50
}

Data Source

This actor uses the OpenFDA Device 510(k) API, a free public API provided by the U.S. Food and Drug Administration. No API key or authentication is required.