Cleared Special

K182846 - PENTAX Medical EPK-3000 Video Imaging S...

K182846 is the FDA 510(k) clearance for PENTAX Medical EPK-3000 Video Imaging S... by Pentax of America, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOB) cleared through the Special 510(k) pathway after a 92-day FDA review.

K182846 · Pentax of America, Inc. · Ear, Nose, Throat device
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Jan 2019
Decision
92d
Days
Class 2
Risk

K182846 is an FDA 510(k) clearance for the PENTAX Medical EPK-3000 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 January 9, 2019 after a review of 92 days - within the typical 510(k) review window.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pentax of America, Inc. devices

Submission Details

510(k) Number K182846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2018
Decision Date January 09, 2019
Days to Decision 92 days
Submission Type Special
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
3d slower than avg
Panel avg: 89d · This submission: 92d
Pathway characteristics
Modification to existing cleared device.

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 K182846.
Ambu aScope 4 RhinoLaryngo Slim
K191080 · Ambu A/S · May 2019
CMOS Video-Rhino-Laryngoscope System
K182186 · KARL STORZ Endoscopy-America, Inc. · Mar 2019
RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4
K182102 · Olympus Medical Systems Corp. · Feb 2019
Ambu aScope RLS Slim
K181286 · Ambu A/S · Nov 2018
Rhino-Laryngo Fiberscope Olympus ENF-GP2
K181240 · Olympus Medical Systems Corp. · Oct 2018
PENTAX Medical VIVIDEO ENT Videoscope Solution
K171011 · Pentax Medical · Jul 2018