Cleared Traditional

RTMsense Respiratory Monitoring System

K243183 · Rtm Vital Signs, LLC · Anesthesiology

Jun 2025

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K243183 is an FDA 510(k) clearance for the RTMsense Respiratory Monitoring System, a Monitor, Breathing Frequency (Class II — Special Controls, product code BZQ), submitted by Rtm Vital Signs, LLC (Ambler, US). The FDA issued a Cleared decision on June 27, 2025, 270 days after receiving the submission on September 30, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number	K243183 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2024
Decision Date	June 27, 2025
Days to Decision	270 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF