Cleared Traditional

Respiree Cardio- Respiratory Monitor System

K250934 · Respiree Pte, Ltd. · Anesthesiology

Aug 2025

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K250934 is an FDA 510(k) clearance for the Respiree Cardio- Respiratory Monitor System, a Monitor, Breathing Frequency (Class II — Special Controls, product code BZQ), submitted by Respiree Pte, Ltd. (Singapore Central, SG). The FDA issued a Cleared decision on August 5, 2025, 130 days after receiving the submission on March 28, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number	K250934 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2025
Decision Date	August 05, 2025
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF