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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

by ATMOS MedizinTechnik GmbH & Co. KG

510(k) K241799Ref 317.0100.0Model Suction unit, thoracic

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241799↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04250365191592 Basic UDI-DI 04250365191592UDI-DIDate8 Apr 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED NumberB-04250365191592 Basic UDI-DI 04250365191592UDI-DIDate8 Apr 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK241799 Date7 Mar 2025ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Trade Name
ATMOS C 051 Thorax
Model / Reference
Suction unit, thoracic, 317.0100.0
Primary DI / UDI-DI
04250365191592
Basic UDI-DI
B-04250365191592
510(k) Number
FDA Product Code
BTA
EMDN Code
A0601010201 Drainage systems with adjustable suction and collection chamber
Models / Variants
Device Class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 878.4780
EU market of registration
Germany
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIa
510(k)
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ATMOS C 051 Thorax system is a portable, powered aspiration device designed for manual or powered secretion removal. It includes a thorax suction unit, an 800ml secretion canister, and various hose systems with connectors (small, medium, large, and Y-connector variants) to facilitate drainage and suction in medical applications. This device falls under the classification of a portable aspiration pump, tailored for use in surgical and post-operative settings where fluid management is critical.

The system is supplied as a reusable medical device, intended for use in controlled clinical environments such as operating rooms or recovery units. It is not MRI-safe and requires proper sterilization between uses. The device is authorized under FDA 510K clearance, MDD, and MDR regulations, with a classification as a Class II medical device. Components such as the universal bracket and standard rail bracket ensure compatibility with existing medical infrastructure, while the charger storage unit supports maintenance and organization.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of medical settings is the ATMOS C 051 Thorax system designed for, and how does its portability factor into its use?

    The ATMOS C 051 Thorax system is specifically designed for controlled clinical environments like operating rooms and recovery units, where manual or powered secretion removal is critical. Its portability allows for flexible placement near patients, ensuring efficient fluid management during surgical and post-operative procedures without being permanently fixed to a single location.

  • How is the ATMOS C 051 Thorax system supplied, and what components are included in the full kit?

    The system is supplied as a reusable medical device and includes a thorax suction unit, an 800ml secretion canister, multiple hose systems with different connectors (small, medium, large, and Y-connector variants), a universal bracket, a standard rail bracket, and a charger storage unit for the bracket. These components ensure compatibility with existing medical infrastructure and facilitate drainage and suction in various clinical scenarios.

  • Is the ATMOS C 051 Thorax system safe for use in MRI environments, and what sterilization process should be followed between uses?

    The ATMOS C 051 Thorax system is explicitly not MRI-safe, so it should never be used in MRI environments. Since it is a reusable device, proper sterilization between uses is required to maintain hygiene and prevent cross-contamination in clinical settings.

  • What connector options are available for the hose systems, and how do they impact clinical flexibility?

    The hose systems come with multiple connector options, including small, medium, and large connectors, as well as Y-connector variants for medium and large sizes. These options allow clinicians to customize the setup based on patient needs, ensuring compatibility with different drainage tubes and medical infrastructure, which enhances flexibility in surgical and post-operative care.

  • What regulatory pathways has the ATMOS C 051 Thorax system undergone, and what does this mean for its use in clinical practice?

    The system has been authorized under FDA 510K clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation), confirming its compliance with stringent safety and performance standards. This regulatory approval ensures that the device meets established requirements for portable aspiration pumps in clinical settings, providing confidence in its reliability and suitability for use in operating rooms and recovery units.

Properties

  • Administering Medicine

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No