Cleared Traditional

LungTrainer (MD2 & MD3)

K221058 · Lung Trainers, LLC · Anesthesiology
Jul 2023
Decision
450d
Days
Class 2
Risk

About This 510(k) Submission

K221058 is an FDA 510(k) clearance for the LungTrainer (MD2 & MD3), a Spirometer, Therapeutic (incentive) (Class II — Special Controls, product code BWF), submitted by Lung Trainers, LLC (Miami, US). The FDA issued a Cleared decision on July 5, 2023, 450 days after receiving the submission on April 11, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5690.

Submission Details

510(k) Number K221058 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2022
Decision Date July 05, 2023
Days to Decision 450 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

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