Cleared Traditional

OMS ANTERIOR CHAMBER INFUSION NEEDLE (K813483) - FDA 510(k) Clearance

K813483 · Optical Micro Systems, Inc. · Ophthalmic device
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Jan 1982
Decision
52d
Days
-
Risk

K813483 is an FDA 510(k) clearance for the OMS ANTERIOR CHAMBER INFUSION NEEDLE.

Submitted by Optical Micro Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 22, 1982 after a review of 52 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 Optical Micro Systems, Inc. devices

Submission Details

510(k) Number K813483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1981
Decision Date January 22, 1982
Days to Decision 52 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 110d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -