Cleared Traditional

K192090 - CMOS Video Rhino-Laryngoscope SSU

K192090 is the FDA 510(k) clearance for CMOS Video Rhino-Laryngoscope SSU by Karl Storz SE & CO. KG. It is a Class 2 Ear, Nose, Throat device (product code EOB) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K192090 · Karl Storz SE & CO. KG · Ear, Nose, Throat device
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Jan 2020
Decision
175d
Days
Class 2
Risk

K192090 is an FDA 510(k) clearance for the CMOS Video Rhino-Laryngoscope SSU. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Karl Storz SE & CO. KG (Tuttlingen, DE). The FDA issued a Cleared decision on January 27, 2020 after a review of 175 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 SE & CO. KG devices

Submission Details

510(k) Number K192090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2019
Decision Date January 27, 2020
Days to Decision 175 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
86d slower than avg
Panel avg: 89d · This submission: 175d
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 K192090.
ENTity WiFi Video Nasopharyngoscope System
K200609 · Optim, LLC · Jan 2021
HD Video Rhino Laryngoscope
K200740 · KARL STORZ Endoscopy-America, Inc. · Aug 2020
Colibri Endoscopy System
K192305 · 3nt Medical , Ltd. · Feb 2020
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