Cleared Traditional

Respiration Data Management Software (PAP Link PC)

K242935 · BMC Medical Co., Ltd. · Anesthesiology

Jan 2025

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K242935 is an FDA 510(k) clearance for the Respiration Data Management Software (PAP Link PC), a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by BMC Medical Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on January 15, 2025, 112 days after receiving the submission on September 25, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K242935 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 2024
Decision Date	January 15, 2025
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF