Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant - Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small

510(k) K250312

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK250312	Date2 Jul 2025Cleared	StatusActive

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

1 jurisdiction

United States — FDA 510(k) Active

510(k)

510(k) Number: K250312
FDA Product Code: BTT
Models / Variants: Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant
Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small