Cleared Traditional

K241799 - ATMOS C 051 Thorax (317.0200.0) (FDA 510(k) Clearance)

Also includes:

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

K241799 · Atmos Medizintechnik GmbH & Co. KG · General & Plastic Surgery device

Mar 2025

Decision

259d

Days

Class 2

Risk

K241799 is an FDA 510(k) clearance for the ATMOS C 051 Thorax (317.0200.0). This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number	K241799 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 21, 2024
Decision Date	March 07, 2025
Days to Decision	259 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF