Cleared Special

K183691 - PENTAX Medical ENT Video Imaging System

K183691 is an FDA 510(k) clearance for PENTAX Medical ENT Video Imaging System, manufactured by Pentax of America, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Special 510(k) pathway after a 163-day FDA review.

K183691 · Pentax of America, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
163d
Days
Class 2
Risk

K183691 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 June 12, 2019 after a review of 163 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. 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.

FDA 510(k) Submission Details - K183691

510(k) Number K183691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2018
Decision Date June 12, 2019
Days to Decision 163 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
73d slower than avg
Panel avg: 90d · This submission: 163d
Pathway characteristics
Modification to existing cleared device.

EOB Device Classification - Class 2, Special Controls

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 162
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K183691.
Rhino-Laryngo Videoscope Olympus ENF-VT3
K183416 · Olympus Medical Systems Corp. · Sep 2019
Precision S 4K Sinuscope
K191102 · Stryker · Sep 2019
Ambu aScope 4 RhinoLaryngo Intervention
K190972 · Ambu A/S · Jul 2019
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
K183691 · PENTAX Medical ENT Video Imaging System
Download PDF FDA Summary Pentax of America, In…