Cleared Traditional

K961090 - AUTOMATIC VISUAL FIELD PLOTTER AP-125

K961090 is an FDA 510(k) clearance for AUTOMATIC VISUAL FIELD PLOTTER AP-125, manufactured by Kowa Optimed, Inc.. The device is a Class 1 Ophthalmic device with product code HPT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K961090 · Kowa Optimed, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
90d
Days
Class 1
Risk

K961090 is an FDA 510(k) clearance for the AUTOMATIC VISUAL FIELD PLOTTER AP-125. Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by Kowa Optimed, Inc. (Washington, US). The FDA issued a Cleared decision on June 17, 1996 after a review of 90 days - within the typical 510(k) review window.

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 Kowa Optimed, Inc. devices

FDA 510(k) Submission Details - K961090

510(k) Number K961090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1996
Decision Date June 17, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
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 11
Devices cleared under the same product code (HPT) and FDA review panel - the closest regulatory comparables to K961090.
TRUEFIELD ANALYZER
K063310 · Seeing Machines Limited · Aug 2007
THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)
K050350 · Notal Vision, Inc. · Apr 2005
KASHA VISUAL FIELD SYSTEM
K971156 · Kasha Software, Inc. · May 1997
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