Data / Medical devices / United States / Atmos Inc.
Atmos Inc.: FDA-registered device maker in Exton, PA, United States, 6 510(k) clearances
Atmos Inc. is registered with the FDA (registration 3005527904) in Exton, PA, United States. It lists 14 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 7, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005527904
- Address
- 29 Dowlin Forge Road, Exton, PA, United States, 19341
- Owner or operator
- ATMOS MEDIZINTECHNIK GMBH & CO. KG (8010573)
- Roles
- Repackager or relabeler
- First device listed
- December 22, 1980
- Registered through
- 2026
- Brand names listed
- ATMOS C 051, ATMOS C 051 Thorax, ATMOS C 361, ATMOS C 451, ATMOS ENT EXAMINATION AND TREATMENT UNITS, ATMOS EXAMINATION LIGHTS, ATMOS LIGHT SOURCES, ATMOS Nasopharyngoscope PED and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 7, 2025 | K241799 | 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 | BTA | Substantially Equivalent | Atmos Medizintechnik GmbH & Co. KG | accessdata.fda.gov |
| August 3, 2023 | K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) | EOB | Substantially Equivalent | Atmos Medizintechnik GmbH & Co. KG | accessdata.fda.gov |
| July 23, 2015 | K150248 | ORL Video NasoPharyngo-Larngoscope | EQN | Substantially Equivalent | Jedmed Instrument Company | accessdata.fda.gov |
| March 4, 2015 | K143673 | CMOS Video Nasopharyngoscope System | EOB | Substantially Equivalent | Schoelly Fiberoptic GmbH | accessdata.fda.gov |
| April 15, 2011 | K103042 | ATMOS E 201 THORAX AND ATMOS S 201 THORAX | BTA | Substantially Equivalent | Atmos, Inc. | accessdata.fda.gov |
| February 27, 2009 | K090445 | ATMOS C361/C451 SUCTION PUMP | BTA | Substantially Equivalent | Atmos, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Nasopharyngoscope (Flexible Or Rigid)
- All makers of Unit, Examining/Treatment, Ent
- All makers of Laryngoscope, Nasopharyngoscope
- All makers of Pump, Portable, Aspiration (Manual Or Powered)
- All makers of Source, Carrier, Fiberoptic Light
- All makers of Colposcope (And Colpomicroscope), Exempt
Updated March 7, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.