Cleared Traditional

AG100s

K221477 · Hospitech Respiration , Ltd. · Anesthesiology
Dec 2022
Decision
220d
Days
Class 2
Risk

About This 510(k) Submission

K221477 is an FDA 510(k) clearance for the AG100s, a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Hospitech Respiration , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on December 29, 2022, 220 days after receiving the submission on May 23, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K221477 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2022
Decision Date December 29, 2022
Days to Decision 220 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSK — Cuff, Tracheal Tube, Inflatable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5750