Cleared Traditional

K912955 - EYE PAD (FDA 510(k) Clearance)

K912955 · Cal West Trading Co. · General & Plastic Surgery device
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Sep 1991
Decision
70d
Days
-
Risk

K912955 is an FDA 510(k) clearance for the EYE PAD. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Cal West Trading Co. (Santa Fe Springs, US). The FDA issued a Cleared decision on September 10, 1991 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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 Cal West Trading Co. devices

Submission Details

510(k) Number K912955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1991
Decision Date September 10, 1991
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 114d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -