Cleared Traditional

K832555 - OCUMAP 100 AUTOPERIMETER

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

K832555 · Shorashim · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K832555

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.

HPT Device Classification - Class 1, General Controls

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 12
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