Cleared Traditional

K832555 - OCUMAP 100 AUTOPERIMETER

K832555 is the FDA 510(k) clearance for OCUMAP 100 AUTOPERIMETER by Shorashim. It is a Class 1 Ophthalmic device (product code HPT) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K832555 · Shorashim · Ophthalmic device
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Feb 1984
Decision
193d
Days
Class 1
Risk

K832555 is an FDA 510(k) clearance for the OCUMAP 100 AUTOPERIMETER. Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by Shorashim (Walker, US). The FDA issued a Cleared decision on February 10, 1984 after a review of 193 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1605 - the FDA ophthalmic 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Shorashim devices

Submission Details

510(k) Number K832555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1983
Decision Date February 10, 1984
Days to Decision 193 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 110d · This submission: 193d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPT Perimeter, Automatic, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1605
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 - HPT Perimeter, Automatic, Ac-powered

All 8
Devices cleared under the same product code (HPT) and FDA review panel - the closest regulatory comparables to K832555.
HUMPHREY FIELD ANALYZER (HFA II)
K954167 · Carl Zeiss, Inc. · Nov 1995
DIGILAB MODEL 1500 PERIMETER
K870120 · Bio-Rad · Feb 1987
DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU
K850191 · Bio-Rad · Mar 1985
DIGILAB 350 THE KRAKAU PERIMETER
K832175 · Bio-Rad · Aug 1983
DICON GLAUCOMA DIAG. CENTER 2000 SERIES
K832142 · CooperVision, Inc. · Aug 1983
AUTO-FIELD D AUTOMATED VISUAL DETECTOR
K800722 · Cavitron Corp. · Apr 1980