# K181292: PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor

- Pathway: 510(k) (Traditional)
- Applicant: Cogentix Medical, Inc.
- Decided: Nov 15, 2018 after 183 days
- Product code: EOX (Esophagoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K921244 (1992). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072088: Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable Endosheath Systems, Vision-Sciences, Inc. (2007) Summary page 4.
- K072180: Vision-Sciences CST-5000 Video Cystoscope with Endosheath System, Vision-Sciences, Inc. (2007) Summary page 5.
- K091768: Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor & Accessories, Vision-Sciences, Inc. (2009) Summary page 5.
- K102733: Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video Processor, Vision-Sciences, Inc. (2011) Summary page 5.

## Indications for use
The PrimeSight™ UNITY 9000 Series Video Processors, when used in conjunction with a Cogentix Medical flexible videoscope, are indicated for the display and management of video and images during trans-nasal esophagoscopy, cystoscopy, bronchoscopy and nasopharyngoscopy procedures.

Source page: https://510kreport.com/device/K181292
Methodology: https://510kreport.com/methodology