Cleared Traditional

K802903 - MICROSCOPE MODEL OM-P

K802903 is the FDA 510(k) clearance for MICROSCOPE MODEL OM-P by Jedmed Instrument Co.. It is a Class 1 General & Plastic Surgery device (product code EPT) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K802903 · Jedmed Instrument Co. · General & Plastic Surgery device
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Feb 1981
Decision
79d
Days
Class 1
Risk

K802903 is an FDA 510(k) clearance for the MICROSCOPE MODEL OM-P. Classified as Microscope, Surgical (product code EPT), Class I - General Controls.

Submitted by Jedmed Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1981 after a review of 79 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 Jedmed Instrument Co. devices

Submission Details

510(k) Number K802903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1980
Decision Date February 04, 1981
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EPT Microscope, Surgical
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 - EPT Microscope, Surgical

All 12
Devices cleared under the same product code (EPT) and FDA review panel - the closest regulatory comparables to K802903.
NAGASHIMA SU-A CEILING MOUNT UNIT FOR
K822014 · Kelleher Corp. · Aug 1982
BINOCULAR OPERATING MICROSCOPES &
K822009 · Kelleher Corp. · Jul 1982
STORZ/OLYMPUS MICROSCOPE SYSTEM
K812234 · Storz Instrument Co. · Sep 1981
MICROSCOPE MODEL OM-U
K802904 · Jedmed Instrument Co. · Feb 1981
REMOTE CONTROL SYSTEM FOR MICROSCOPE
K760696 · Alcon Laboratories · Dec 1976