Cleared Traditional

Respond OC Conserving Regulator (130-0800)

K250322 · Responsive Respiratory · Anesthesiology

Jul 2025

Decision

170d

Days

Class 2

Risk

About This 510(k) Submission

K250322 is an FDA 510(k) clearance for the Respond OC Conserving Regulator (130-0800), a Conserver, Oxygen (Class II — Special Controls, product code NFB), submitted by Responsive Respiratory (St. Louis, US). The FDA issued a Cleared decision on July 24, 2025, 170 days after receiving the submission on February 4, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K250322 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2025
Decision Date	July 24, 2025
Days to Decision	170 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF