Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
Summary
Medline Industries, LP received 510(k) clearance for Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small, a BTT device. Cleared on 2025-07-02.
Details
Source
510(k) Clearance
External ID
K250312
Action Date
2025-07-02
Status
Traditional
Category
device
Product Code
BTT
Product Description
Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small. Product code: BTT.
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 413 device clearances issued this month. Medline Industries, LP has received 27 total clearances in our database.
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 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, LP have FDA actions?
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K250312" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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