Bluebird Single-Use Respiratory Effort Belt
Summary
Cadwell Industries, Inc. received 510(k) clearance for Bluebird Single-Use Respiratory Effort Belt, a MNR device. Cleared on 2024-12-18.
Details
Source
510(k) Clearance
External ID
K242424
Action Date
2024-12-18
Status
Traditional
Category
device
Product Code
MNR
Product Description
Bluebird Single-Use Respiratory Effort Belt. Product code: MNR.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Cadwell Industries, Inc. has received 3 total clearances in our database.
Cadwell Industries, Inc. has 5 FDA actions in our database, including 2 recalls and 3 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Cadwell Industries, Inc. have FDA actions?
Cadwell Industries, Inc. has 5 FDA actions in our database, including 2 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K242424" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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