Cleared Traditional

K954167 - HUMPHREY FIELD ANALYZER (HFA II)

K954167 is the FDA 510(k) clearance for HUMPHREY FIELD ANALYZER (HFA II) by Carl Zeiss, Inc.. It is a Class 1 Ophthalmic device (product code HPT) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K954167 · Carl Zeiss, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Nov 1995
Decision
80d
Days
Class 1
Risk

K954167 is an FDA 510(k) clearance for the HUMPHREY FIELD ANALYZER (HFA II). Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on November 24, 1995 after a review of 80 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 Carl Zeiss, Inc. devices

Submission Details

510(k) Number K954167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1995
Decision Date November 24, 1995
Days to Decision 80 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 110d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 7
Devices cleared under the same product code (HPT) and FDA review panel - the closest regulatory comparables to K954167.
GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES
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