Hudson RCI Triflo II Incentive Deep Breathing Exerciser
Summary
Medline Industries, Inc. received 510(k) clearance for Hudson RCI Triflo II Incentive Deep Breathing Exerciser, a BWF device. Cleared on 2022-10-25.
Details
Source
510(k) Clearance
External ID
K220565
Action Date
2022-10-25
Status
Traditional
Category
device
Product Code
BWF
Product Description
Hudson RCI Triflo II Incentive Deep Breathing Exerciser. Product code: BWF.
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. Medline Industries, Inc. has received 13 total clearances in our database.
Medline Industries, Inc. has 27 FDA actions in our database, including 14 recalls and 13 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 Medline Industries, Inc. have FDA actions?
Medline Industries, Inc. has 27 FDA actions in our database, including 14 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K220565" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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