Cleared Traditional

K853454 - SURE COUNT 5 & 10 SPONGE COUNTER (FDA 510(k) Clearance)

K853454 · Kleen Test Products · General & Plastic Surgery device
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Sep 1985
Decision
20d
Days
-
Risk

K853454 is an FDA 510(k) clearance for the SURE COUNT 5 & 10 SPONGE COUNTER.

Submitted by Kleen Test Products (Milwaukee, US). The FDA issued a Cleared decision on September 5, 1985 after a review of 20 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.

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Submission Details

510(k) Number K853454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1985
Decision Date September 05, 1985
Days to Decision 20 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 114d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -