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FDA 510(k) Clearance Tracker

Pricing

$10.00 / 1,000 result delivereds

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FDA 510(k) Clearance Tracker

FDA 510(k) Clearance Tracker

Live openFDA 510(k) rows. Try includes Electrical Muscle Stimulator K261131. Not a predicate decision. $0.02 / row.

Pricing

$10.00 / 1,000 result delivereds

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Developer

Zentra

Zentra

Maintained by Community

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1

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4 days ago

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K261131 is a real clearance, not a sample 510(k).

Live openFDA 510(k) rows. Try includes Electrical Muscle Stimulator K261131. Not a predicate decision. $0.02 / row.

Last run

8 row(s). First row: Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-

{
"title": "Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-",
"sourceName": "openFDA Device 510(k) API",
"sourceUrl": "https://api.fda.gov/device/510k.json",
"status": "cleared",
"summary": "FDA 510(k) K261131 cleared 2026-09-06 for Shenzhen Osto Medical Technology Co.,Ltd."
}

Run it

Paste this on the Input tab (JSON) and press Start. That is the same input the last-run used.

{
"sourceMode": "live",
"outputMode": "live-records",
"maxItems": 8,
"startUrls": [
{
"url": "https://api.fda.gov/device/510k.json?limit=10&sort=decision_date:desc"
}
]
}

What lands in the dataset

  • openFDA 510(k)
  • K-number + device name
  • Live stimulator row

Use it when

openFDA 510(k). K261131 muscle stimulator is a live clearance.

Device competitors watching 510(k) drops.

Price

$0.02 / 510(k) row — you pay $0.02 per billed result. A 10-row Try is about $0.20.

Schedule it. A one-off curiosity click is not the product.

What you should know

  • Not a regulatory determination.
  • US FDA only.

FAQ

Is the last-run a fixture? No. The JSON above is from the public source in Run it.

A predicate device graph? No. Live openFDA 510(k) rows. Try includes K261131.