Cleared Traditional

K971156 - KASHA VISUAL FIELD SYSTEM

K971156 is an FDA 510(k) clearance for KASHA VISUAL FIELD SYSTEM, manufactured by Kasha Software, Inc.. The device is a Class 1 Ophthalmic device with product code HPT cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K971156 · Kasha Software, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
61d
Days
Class 1
Risk

K971156 is an FDA 510(k) clearance for the KASHA VISUAL FIELD SYSTEM. Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by Kasha Software, Inc. (Charlotte, US). The FDA issued a Cleared decision on May 28, 1997 after a review of 61 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 Kasha Software, Inc. devices

FDA 510(k) Submission Details - K971156

510(k) Number K971156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1997
Decision Date May 28, 1997
Days to Decision 61 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
49d faster than avg
Panel avg: 110d · This submission: 61d
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 8
Devices cleared under the same product code (HPT) and FDA review panel - the closest regulatory comparables to K971156.
GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES
K093213 · Carl Zeiss Meditec, Inc. · Mar 2010
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