Cleared Traditional

K822601 - FIXATION MONITOR

K822601 is an FDA 510(k) clearance for FIXATION MONITOR, manufactured by West Coast Optical Instruments, Inc.. The device is a Class 1 Ophthalmic device with product code HPT cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K822601 · West Coast Optical Instruments, Inc. · Ophthalmic device
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Sep 1982
Decision
34d
Days
Class 1
Risk

K822601 is an FDA 510(k) clearance for the FIXATION MONITOR. Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by West Coast Optical Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 30, 1982 after a review of 34 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 - K822601

510(k) Number K822601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1982
Decision Date September 30, 1982
Days to Decision 34 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
76d faster than avg
Panel avg: 110d · This submission: 34d
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 38
Devices cleared under the same product code (HPT) and FDA review panel - the closest regulatory comparables to K822601.
DICON GLAUCOMA DIAG. CENTER 2000 SERIES
K832142 · CooperVision, Inc. · Aug 1983
MODEL 200 SQUID
K822853 · Synemed, Inc. · Oct 1982
AUTO PERIOMETER 3000
K822580 · Dicon, Inc. · Sep 1982
THE HUMPHREY FIELD ANALYZER MODEL 610
K821940 · Zeiss Humphrey System · Jul 1982
DICON AUTO PERIMETER 200
K811346 · Dicon, Inc. · Aug 1981
DICON AUTO PERIMETER 2000
K811347 · Dicon, Inc. · Aug 1981
K822601 · FIXATION MONITOR
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