Cleared Traditional

K182186 - CMOS Video-Rhino-Laryngoscope System

K182186 is the FDA 510(k) clearance for CMOS Video-Rhino-Laryngoscope System by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOB) cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K182186 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
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Mar 2019
Decision
221d
Days
Class 2
Risk

K182186 is an FDA 510(k) clearance for the CMOS Video-Rhino-Laryngoscope System. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on March 22, 2019 after a review of 221 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K182186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2018
Decision Date March 22, 2019
Days to Decision 221 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
132d slower than avg
Panel avg: 89d · This submission: 221d
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 99
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K182186.
Ambu aScope 4 RhinoLaryngo Intervention
K190972 · Ambu A/S · Jul 2019
PENTAX Medical ENT Video Imaging System
K183691 · Pentax of America, Inc. · Jun 2019
Ambu aScope 4 RhinoLaryngo Slim
K191080 · Ambu A/S · May 2019
RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4
K182102 · Olympus Medical Systems Corp. · Feb 2019
PENTAX Medical EPK-3000 Video Imaging System
K182846 · Pentax of America, Inc. · Jan 2019
Ambu aScope RLS Slim
K181286 · Ambu A/S · Nov 2018