Cleared Traditional

Acapella Choice Blue Vibratory PEP Device

K181660 · Smiths Medical · Anesthesiology
Oct 2019
Decision
486d
Days
Class 2
Risk

About This 510(k) Submission

K181660 is an FDA 510(k) clearance for the Acapella Choice Blue Vibratory PEP Device, a Spirometer, Therapeutic (incentive) (Class II — Special Controls, product code BWF), submitted by Smiths Medical (Plymouth, US). The FDA issued a Cleared decision on October 24, 2019, 486 days after receiving the submission on June 25, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5690.

Submission Details

510(k) Number K181660 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2018
Decision Date October 24, 2019
Days to Decision 486 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