Cleared Traditional

ENT Nasopharyngoscope and Accessories (K214050) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K214050 · Medimaging Integrated Solution, Inc (Miis) · Ear, Nose, Throat device
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Jul 2022
Decision
186d
Days
Class 2
Risk

K214050 is an FDA 510(k) clearance for the ENT Nasopharyngoscope and Accessories. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Medimaging Integrated Solution, Inc (Miis) (Hsinchu, TW). The FDA issued a Cleared decision on July 1, 2022 after a review of 186 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 Medimaging Integrated Solution, Inc (Miis) devices

Submission Details

510(k) Number K214050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2021
Decision Date July 01, 2022
Days to Decision 186 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
97d slower than avg
Panel avg: 89d · This submission: 186d
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 66
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K214050.
Single-Use Flexible Rhinolaryngoscope
K221581 · Hunan Vathin Medical Instrument Co., Ltd. · Nov 2022
PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10
K220465 · Pentax of America, Inc. · Nov 2022
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
K221638 · Olympus Medical Systems Corp. · Sep 2022
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