Cleared Traditional

ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System

K202461 · Smisson-Cartledge Biomedical, LLC · General Hospital

Aug 2022

Decision

715d

Days

Class 2

Risk

About This 510(k) Submission

K202461 is an FDA 510(k) clearance for the ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System, a Warmer, Thermal, Infusion Fluid (Class II — Special Controls, product code LGZ), submitted by Smisson-Cartledge Biomedical, LLC (Macon, US). The FDA issued a Cleared decision on August 12, 2022, 715 days after receiving the submission on August 27, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K202461 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 2020
Decision Date	August 12, 2022
Days to Decision	715 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF