Cleared Traditional

K200740 - HD Video Rhino Laryngoscope

K200740 is the FDA 510(k) clearance for HD Video Rhino Laryngoscope 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 141-day FDA review.

K200740 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
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Aug 2020
Decision
141d
Days
Class 2
Risk

K200740 is an FDA 510(k) clearance for the HD Video Rhino Laryngoscope. 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 August 11, 2020 after a review of 141 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. 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 K200740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2020
Decision Date August 11, 2020
Days to Decision 141 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
52d slower than avg
Panel avg: 89d · This submission: 141d
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 100
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K200740.
Zsquare ENT-Flex Endoscope
K220004 · Zsquare, Ltd. · Jun 2022
Peregrine Endoscopy System
K202727 · 3nt Medical , Ltd. · Jul 2021
ENTity WiFi Video Nasopharyngoscope System
K200609 · Optim, LLC · Jan 2021
Colibri Endoscopy System
K192305 · 3nt Medical , Ltd. · Feb 2020
CMOS Video Rhino-Laryngoscope SSU
K192090 · Karl Storz SE & CO. KG · Jan 2020
Rhino-Laryngo Videoscope Olympus ENF-VT3
K183416 · Olympus Medical Systems Corp. · Sep 2019