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

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241799 · Atmos Medizintechnik GmbH & Co. KG · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
259d
Days
Class 2
Risk

K241799 is an FDA 510(k) clearance for the ATMOS C 051 Thorax (317.0200.0). Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Atmos Medizintechnik GmbH & Co. KG (Lenzkirch, DE). The FDA issued a Cleared decision on March 7, 2025 after a review of 259 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Atmos Medizintechnik GmbH & Co. KG devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 114d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTA Pump, Portable, Aspiration (manual Or Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 154
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