Cleared Traditional

K171011 - PENTAX Medical VIVIDEO ENT Videoscope S...

K171011 is the FDA 510(k) clearance for PENTAX Medical VIVIDEO ENT Videoscope S... by Pentax Medical. It is a Class 2 Ear, Nose, Throat device (product code EOB) cleared through the Traditional 510(k) pathway after a 470-day FDA review.

K171011 · Pentax Medical · Ear, Nose, Throat device
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Jul 2018
Decision
470d
Days
Class 2
Risk

K171011 is an FDA 510(k) clearance for the PENTAX Medical VIVIDEO ENT Videoscope Solution. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Pentax Medical (Montvale, US). The FDA issued a Cleared decision on July 18, 2018 after a review of 470 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Pentax Medical devices

Submission Details

510(k) Number K171011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2017
Decision Date July 18, 2018
Days to Decision 470 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
381d slower than avg
Panel avg: 89d · This submission: 470d
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 86
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K171011.
PENTAX Medical EPK-3000 Video Imaging System
K182846 · Pentax of America, Inc. · Jan 2019
Ambu aScope RLS Slim
K181286 · Ambu A/S · Nov 2018
Rhino-Laryngo Fiberscope Olympus ENF-GP2
K181240 · Olympus Medical Systems Corp. · Oct 2018
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