About This 510(k) Submission
K241799 is an FDA 510(k) clearance for the ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C, a Pump, Portable, Aspiration (manual Or Powered) (Class II — Special Controls, product code BTA), submitted by Atmos Medizintechnik GmbH & Co. KG (Lenzkirch, DE). The FDA issued a Cleared decision on March 7, 2025, 259 days after receiving the submission on June 21, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.