# K132009: Cmos Video Nasopharyngoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Schoelly Fiberoptic GmbH
- Decided: Apr 9, 2014 after 282 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: 2 generations back to K991560 (1999). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103467: Cmos Video Rhino-Laryngoscope System Model 11101CM, KARL STORZ Endoscopy-America, Inc. (2012) Summary page 1.
- K083553: Naso-Laryngo-Pharyngoscope, Schoelly Imaging, Inc. (2009) Summary page 1.

## Most influential descendants
- K143673: CMOS Video Nasopharyngoscope System (2015), 1 descendant of its own
- K232015: ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) (2023), 0 descendants of its own
- K222587: PatCom Distal Chip Endoscope (2023), 0 descendants of its own

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

Source page: https://510kreport.com/device/K132009
Methodology: https://510kreport.com/methodology