Cleared Traditional

K803159 - AUTOMATED PERIMETERS

K803159 is an FDA 510(k) clearance for AUTOMATED PERIMETERS, manufactured by Coburn Optical Ind., Inc.. The device is a Class 1 Ophthalmic device with product code HPT cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K803159 · Coburn Optical Ind., Inc. · Ophthalmic device
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Feb 1981
Decision
58d
Days
Class 1
Risk

K803159 is an FDA 510(k) clearance for the AUTOMATED PERIMETERS. Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by Coburn Optical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1981 after a review of 58 days - a notably fast clearance 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: 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 Coburn Optical Ind., Inc. devices

FDA 510(k) Submission Details - K803159

510(k) Number K803159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1980
Decision Date February 04, 1981
Days to Decision 58 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 110d · This submission: 58d
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 K803159.
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
AUTO-FIELD II OPHTHALMIC FIELD SCANNER
K781462 · Cavitron Corp. · Sep 1978