Cleared Traditional

K181292 - PrimeSight UNITY 9000 Video Processor

K181292 is the FDA 510(k) clearance for PrimeSight UNITY 9000 Video Processor by Cogentix Medical, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOX) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K181292 · Cogentix Medical, Inc. · Ear, Nose, Throat device
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Nov 2018
Decision
183d
Days
Class 2
Risk

K181292 is an FDA 510(k) clearance for the PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor. Classified as Esophagoscope (flexible Or Rigid) (product code EOX), Class II - Special Controls.

Submitted by Cogentix Medical, Inc. (Orangeburg, US). The FDA issued a Cleared decision on November 15, 2018 after a review of 183 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4710 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Cogentix Medical, Inc. devices

Submission Details

510(k) Number K181292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2018
Decision Date November 15, 2018
Days to Decision 183 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 89d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOX Esophagoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4710
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOX Esophagoscope (flexible Or Rigid)

All 22
Devices cleared under the same product code (EOX) and FDA review panel - the closest regulatory comparables to K181292.
CMOS Video Esophagoscope SSU
K192523 · Karl Storz SE & CO. KG · Jan 2020
EsoCheck CCD Cell Collection Device
K183262 · Lucid Diagnostics, Inc. · Jun 2019
Strome-Blitzer Cytology Balloon
K182159 · Adn International, LLC · Jun 2019
Cytosponge Cell Collection Device
K181020 · Covidien, LLC · Aug 2018
Cytosponge Cell Collection Device
K152794 · Covidien, LLC · Apr 2016
Cytosponge Cell Collection Device
K142695 · Covidien, LLC · Nov 2014