Cleared Traditional

K791295 - BAYLOR VISUAL FIELDS PROGRAMMER

K791295 is an FDA 510(k) clearance for BAYLOR VISUAL FIELDS PROGRAMMER, manufactured by Schiff Harding Waite. The device is a Class 1 Ophthalmic device with product code HPT cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K791295 · Schiff Harding Waite · Ophthalmic device
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Aug 1979
Decision
31d
Days
Class 1
Risk

K791295 is an FDA 510(k) clearance for the BAYLOR VISUAL FIELDS PROGRAMMER. Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by Schiff Harding Waite (Mchenry, US). The FDA issued a Cleared decision on August 10, 1979 after a review of 31 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.

FDA 510(k) Submission Details - K791295

510(k) Number K791295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1979
Decision Date August 10, 1979
Days to Decision 31 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 110d · This submission: 31d
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 40
Devices cleared under the same product code (HPT) and FDA review panel - the closest regulatory comparables to K791295.
DICON AUTO PERIMETER 2000
K811347 · Dicon, Inc. · Aug 1981
AUTOMATED PERIMETERS
K803159 · Coburn Optical Ind., Inc. · Feb 1981
AUTO-FIELD D AUTOMATED VISUAL DETECTOR
K800722 · Cavitron Corp. · Apr 1980
AUTO-FIELD II OPHTHALMIC FIELD SCANNER
K781462 · Cavitron Corp. · Sep 1978
OCTOPUS
K780414 · Hitron Corp. · Apr 1978
K791295 · BAYLOR VISUAL FIELDS PROGRAMMER
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