Cleared Traditional

K162151 - PENTAX Medical ENT Video Imaging System

K162151 is the FDA 510(k) clearance for PENTAX Medical ENT Video Imaging System by Pentax of America, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOB) cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K162151 · Pentax of America, Inc. · Ear, Nose, Throat device
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Apr 2017
Decision
261d
Days
Class 2
Risk

K162151 is an FDA 510(k) clearance for the PENTAX Medical ENT Video Imaging System. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Pentax of America, Inc. (Montvale, US). The FDA issued a Cleared decision on April 20, 2017 after a review of 261 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4760 - 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 Pentax of America, Inc. devices

Submission Details

510(k) Number K162151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2016
Decision Date April 20, 2017
Days to Decision 261 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
172d slower than avg
Panel avg: 89d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOB Nasopharyngoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4760
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 - EOB Nasopharyngoscope (flexible Or Rigid)

All 85
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K162151.
Sharpsite AC Rigid Endsocope
K173855 · Medtronic Xomed, Inc. · Apr 2018
PENTAX Medical EPK-3000 Video Imaging System
K172156 · Pentax Medical · Apr 2018
KARL STORZ Slim Nasopharyngolaryngoscope
K171402 · KARL STORZ Endoscopy-America, Inc. · Feb 2018
TIPCAM 1S 3D System
K162410 · KARL STORZ Endoscopy-America, Inc. · Mar 2017
ULTRA Telescopes
K153009 · Olympus Winter & Ibe GmbH · Apr 2016
InstaClear Lens Cleaner
K152531 · Gyrus Acmi, Inc. · Jan 2016