Cleared Traditional

K852258 - SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER (FDA 510(k) Clearance)

K852258 · Kleen Test Products · General & Plastic Surgery device
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Jun 1985
Decision
34d
Days
-
Risk

K852258 is an FDA 510(k) clearance for the SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER.

Submitted by Kleen Test Products (Milwaukee, US). The FDA issued a Cleared decision on June 27, 1985 after a review of 34 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 K852258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1985
Decision Date June 27, 1985
Days to Decision 34 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
80d faster than avg
Panel avg: 114d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -