Cleared Traditional

STERILE EYE PACKS OR TRAYS (K852229) - FDA 510(k) Clearance

K852229 · Surgeon Surgical Instrumentation, Inc. · Ophthalmic device
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Jun 1985
Decision
16d
Days
-
Risk

K852229 is an FDA 510(k) clearance for the STERILE EYE PACKS OR TRAYS.

Submitted by Surgeon Surgical Instrumentation, Inc. (Anaheim, US). The FDA issued a Cleared decision on June 7, 1985 after a review of 16 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 Surgeon Surgical Instrumentation, Inc. devices

Submission Details

510(k) Number K852229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1985
Decision Date June 07, 1985
Days to Decision 16 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 110d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -