Cleared Traditional

K891584 - S 22 INSTRUMENT STAND (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K891584 · Carl Zeiss, Inc. · General & Plastic Surgery device
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Jun 1989
Decision
80d
Days
Class 1
Risk

K891584 is an FDA 510(k) clearance for the S 22 INSTRUMENT STAND. Classified as Microscope, Operating & Accessories, Ac-powered, Ophthalmic (product code HRM), Class I - General Controls.

Submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on June 8, 1989 after a review of 80 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 K891584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1989
Decision Date June 08, 1989
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 114d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HRM Microscope, Operating & Accessories, Ac-powered, Ophthalmic
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.