Cleared Traditional

K962649 - SPORTROL RAPID STERILITY INDICATOR (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K962649 · North American Science Assoc., Inc. · General Hospital
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Sep 1997
Decision
445d
Days
Class 2
Risk

K962649 is an FDA 510(k) clearance for the SPORTROL RAPID STERILITY INDICATOR. Classified as Indicator, Chemical, Enzymatic, Sterilization Process (product code MTC), Class II - Special Controls.

Submitted by North American Science Assoc., Inc. (Northwood, US). The FDA issued a Cleared decision on September 26, 1997 after a review of 445 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all North American Science Assoc., Inc. devices

Submission Details

510(k) Number K962649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1996
Decision Date September 26, 1997
Days to Decision 445 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
316d slower than avg
Panel avg: 129d · This submission: 445d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MTC Indicator, Chemical, Enzymatic, Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.