Cleared Traditional

PUPIL PATHWAY ANALYZER (PPA) (K895609) - FDA 510(k) Clearance

Class I Ophthalmic device.

K895609 · Pulse Medical Instruments · Ophthalmic device
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Nov 1989
Decision
45d
Days
Class 1
Risk

K895609 is an FDA 510(k) clearance for the PUPIL PATHWAY ANALYZER (PPA). Classified as Pupillometer, Ac-powered (product code HLG), Class I - General Controls.

Submitted by Pulse Medical Instruments (Costa Mesa, US). The FDA issued a Cleared decision on November 2, 1989 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1700 - 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 Pulse Medical Instruments devices

Submission Details

510(k) Number K895609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1989
Decision Date November 02, 1989
Days to Decision 45 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 110d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HLG Pupillometer, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1700
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.