Cleared Traditional

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

K250093 · Linshom Medical, Inc. · Anesthesiology

Sep 2025

Decision

255d

Days

Class 2

Risk

About This 510(k) Submission

K250093 is an FDA 510(k) clearance for the Linshom Continuous Predictive Respiratory Monitoring System (CPRMS), a Monitor, Breathing Frequency (Class II — Special Controls, product code BZQ), submitted by Linshom Medical, Inc. (Ellicott City, US). The FDA issued a Cleared decision on September 26, 2025, 255 days after receiving the submission on January 14, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number	K250093 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 14, 2025
Decision Date	September 26, 2025
Days to Decision	255 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF