Cleared Traditional

Pylant Monitor

K191858 · Kal-Med, LLC · Anesthesiology
Feb 2020
Decision
228d
Days
Class 2
Risk

About This 510(k) Submission

K191858 is an FDA 510(k) clearance for the Pylant Monitor, a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Kal-Med, LLC (Kensington, US). The FDA issued a Cleared decision on February 24, 2020, 228 days after receiving the submission on July 11, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K191858 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2019
Decision Date February 24, 2020
Days to Decision 228 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