Cleared Special

K222655 - OtoSight Middle Ear Scope (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K222655 · Photonicare, Inc. · Ear, Nose, Throat device
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Sep 2022
Decision
24d
Days
Class 2
Risk

K222655 is an FDA 510(k) clearance for the OtoSight Middle Ear Scope. Classified as Device System, Imaging, Tympanic Membrane And Middle Ear (product code QJG), Class II - Special Controls.

Submitted by Photonicare, Inc. (Champaign, US). The FDA issued a Cleared decision on September 26, 2022 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 892.1560 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Photonicare, Inc. devices

Submission Details

510(k) Number K222655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2022
Decision Date September 26, 2022
Days to Decision 24 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
65d faster than avg
Panel avg: 89d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QJG Device System, Imaging, Tympanic Membrane And Middle Ear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
Definition Is Intended For Use As An Imaging Tool For Visualization Of The Human Tympanic Membrane And Middle Ear Space.
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.