Cleared Traditional

K942233 - MKM (MULTIPLE COORDINATE MANIPULATOR) S...

K942233 is the FDA 510(k) clearance for MKM (MULTIPLE COORDINATE MANIPULATOR) S... by Carl Zeiss, Inc.. It is a Class 1 General & Plastic Surgery device (product code EPT) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K942233 · Carl Zeiss, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
53d
Days
Class 1
Risk

K942233 is an FDA 510(k) clearance for the MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM. Classified as Microscope, Surgical (product code EPT), Class I - General Controls.

Submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on July 1, 1994 after a review of 53 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 Carl Zeiss, Inc. devices

Submission Details

510(k) Number K942233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1994
Decision Date July 01, 1994
Days to Decision 53 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 115d · This submission: 53d
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 K942233.
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