Cleared Traditional

K812234 - STORZ/OLYMPUS MICROSCOPE SYSTEM

K812234 is the FDA 510(k) clearance for STORZ/OLYMPUS MICROSCOPE SYSTEM by Storz Instrument Co.. It is a Class 1 Hematology device (product code EPT) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K812234 · Storz Instrument Co. · Hematology device
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Sep 1981
Decision
31d
Days
Class 1
Risk

K812234 is an FDA 510(k) clearance for the STORZ/OLYMPUS MICROSCOPE SYSTEM. Classified as Microscope, Surgical (product code EPT), Class I - General Controls.

Submitted by Storz Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1981 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 878.4700 - the FDA hematology 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 Storz Instrument Co. devices

Submission Details

510(k) Number K812234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1981
Decision Date September 11, 1981
Days to Decision 31 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 113d · This submission: 31d
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 K812234.
MICROSCOPE
K822561 · Treace Medical, Inc. · Sep 1982
NAGASHIMA SU-A CEILING MOUNT UNIT FOR
K822014 · Kelleher Corp. · Aug 1982
BINOCULAR OPERATING MICROSCOPES &
K822009 · Kelleher Corp. · Jul 1982
MICROSCOPE MODEL OM-P
K802903 · Jedmed Instrument Co. · Feb 1981
MICROSCOPE MODEL OM-U
K802904 · Jedmed Instrument Co. · Feb 1981
REMOTE CONTROL SYSTEM FOR MICROSCOPE
K760696 · Alcon Laboratories · Dec 1976