Cleared Traditional

Bluebird Single-Use Respiratory Effort Belt

K242424 · Cadwell Industries, Inc. · Anesthesiology
Dec 2024
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K242424 is an FDA 510(k) clearance for the Bluebird Single-Use Respiratory Effort Belt, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Cadwell Industries, Inc. (Kennewick, US). The FDA issued a Cleared decision on December 18, 2024, 125 days after receiving the submission on August 15, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K242424 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2024
Decision Date December 18, 2024
Days to Decision 125 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNR — Ventilatory Effort Recorder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375