Cleared Traditional

WAVICIDE MONITOR STRIPS (K932047) - FDA 510(k) Clearance

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

K932047 · Serim Research Corp. · General Hospital
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Jun 1994
Decision
401d
Days
Class 2
Risk

K932047 is an FDA 510(k) clearance for the WAVICIDE MONITOR STRIPS. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on June 2, 1994 after a review of 401 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - 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 Serim Research Corp. devices

Submission Details

510(k) Number K932047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1993
Decision Date June 02, 1994
Days to Decision 401 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
272d slower than avg
Panel avg: 129d · This submission: 401d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MED Sterilant, Medical Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6885
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.

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