Cleared Traditional

K902076 - J2 MICROSCOPE

K902076 is the FDA 510(k) clearance for J2 MICROSCOPE by Jedmed Instrument Co.. It is a Class 1 General & Plastic Surgery device (product code FSO) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K902076 · Jedmed Instrument Co. · General & Plastic Surgery device

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Aug 1990

Decision

85d

Days

Class 1

Risk

K902076 is an FDA 510(k) clearance for the J2 MICROSCOPE. Classified as Microscope, Surgical, General & Plastic Surgery (product code FSO), Class I - General Controls.

Submitted by Jedmed Instrument Co. (St.Louis, US). The FDA issued a Cleared decision on August 1, 1990 after a review of 85 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	K902076 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 08, 1990
Decision Date	August 01, 1990
Days to Decision	85 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

30d faster than avg

Panel avg: 115d · This submission: 85d

Pathway characteristics

Predicate-based equivalence.

Device Classification

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 7

Devices cleared under the same product code (FSO) and FDA review panel - the closest regulatory comparables to K902076.

SOM 6VI (SURGICAL OPERATING MICROSCOPE)

K926288 · Jedmed Instrument Co. · Oct 1993

SOM 6V

K910357 · Jedmed Instrument Co. · Feb 1991

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

BINOCULAR OPERATING MICROSCOPES AND

K822015 · Kelleher Corp. · Jul 1982

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K902076

Jedmed Instrument Co.

St.Louis, MO · US

CRAIG RAPP

Regulatory profile

92 submissions 91 cleared

99% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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