# K232015: ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)

- Pathway: 510(k) (Traditional)
- Applicant: Atmos Medizintechnik GmbH & Co. KG
- Decided: Aug 3, 2023 after 28 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K991560 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143673: CMOS Video Nasopharyngoscope System, Schoelly Fiberoptic GmbH (2015) Summary page 4.

## Indications for use
ATMOS Scope is used for endoscopic diagnosis within the nasal lumens and airway anatomy and is intended to provide visualization via a monitor. The ATMOS Scope may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique.

Source page: https://510kreport.com/device/K232015
Methodology: https://510kreport.com/methodology