Cleared Traditional

OCULOPRESSOR (K832477) - FDA 510(k) Clearance

K832477 · Hans Gevder · Ophthalmic device
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Aug 1983
Decision
21d
Days
-
Risk

K832477 is an FDA 510(k) clearance for the OCULOPRESSOR.

Submitted by Hans Gevder (Mchenry, US). The FDA issued a Cleared decision on August 16, 1983 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. 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 Hans Gevder devices

Submission Details

510(k) Number K832477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1983
Decision Date August 16, 1983
Days to Decision 21 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 110d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -