Cleared Traditional

Hudson RCI Triflo II Incentive Deep Breathing Exerciser

K220565 · Medline Industries, Inc. · Anesthesiology
Oct 2022
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K220565 is an FDA 510(k) clearance for the Hudson RCI Triflo II Incentive Deep Breathing Exerciser, a Spirometer, Therapeutic (incentive) (Class II — Special Controls, product code BWF), submitted by Medline Industries, Inc. (Northfield, US). The FDA issued a Cleared decision on October 25, 2022, 239 days after receiving the submission on February 28, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5690.

Submission Details

510(k) Number K220565 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2022
Decision Date October 25, 2022
Days to Decision 239 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BWF — Spirometer, Therapeutic (incentive)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5690

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