Cleared Traditional

K822015 - BINOCULAR OPERATING MICROSCOPES AND

K822015 is an FDA 510(k) clearance for BINOCULAR OPERATING MICROSCOPES AND, manufactured by Kelleher Corp.. The device is a Class 1 General & Plastic Surgery device with product code FSO cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K822015 · Kelleher Corp. · General & Plastic Surgery device
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Jul 1982
Decision
22d
Days
Class 1
Risk

K822015 is an FDA 510(k) clearance for the BINOCULAR OPERATING MICROSCOPES AND. Classified as Microscope, Surgical, General & Plastic Surgery (product code FSO), Class I - General Controls.

Submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on July 30, 1982 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4700 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kelleher Corp. devices

FDA 510(k) Submission Details - K822015

510(k) Number K822015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1982
Decision Date July 30, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

FSO Device Classification - Class 1, General Controls

Product Code FSO Microscope, Surgical, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FSO Microscope, Surgical, General & Plastic Surgery

All 10
Devices cleared under the same product code (FSO) and FDA review panel - the closest regulatory comparables to K822015.
OPMI MD SURGICAL MICROSCOPE
K874241 · Carl Zeiss, Inc. · Dec 1987
ODONTO-SCOPE
K822562 · Treace Medical, Inc. · Oct 1982
BINOCULAR OPER. MICROSCOPES & ACCESSOR
K822181 · Kelleher Corp. · Aug 1982
FMS-02 FLOOR-UNIT MODEL MICROSCOPE
K802713 · Jedmed Instrument Co. · Nov 1980
VOCON MODEL VC526
K801314 · Teknar, Inc. · Sep 1980
OPERATION MICROSCOPE SOM 1
K791280 · Elmed, Inc. · Jul 1979