Cleared Traditional

K961289 - VAPOPHENE

K961289 is an FDA 510(k) clearance for VAPOPHENE, manufactured by Germiphene Corp.. The device is a Class 2 General Hospital device with product code MED cleared through the Traditional 510(k) pathway after a 609-day FDA review.

K961289 · Germiphene Corp. · General Hospital
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Dec 1997
Decision
609d
Days
Class 2
Risk

K961289 is an FDA 510(k) clearance for the VAPOPHENE. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Germiphene Corp. (Brantford, Ont, CA). The FDA issued a Cleared decision on December 4, 1997 after a review of 609 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 Germiphene Corp. devices

FDA 510(k) Submission Details - K961289

510(k) Number K961289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1996
Decision Date December 04, 1997
Days to Decision 609 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
480d slower than avg
Panel avg: 129d · This submission: 609d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MED Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MED Sterilant, Medical Devices

All 35
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