Cleared Traditional

NOVIGUARD QUICK DRY (K961044) - FDA 510(k) Clearance

Class I General Hospital device.

K961044 · Dr. Novis Smith & Co., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
476d
Days
Class 1
Risk

K961044 is an FDA 510(k) clearance for the NOVIGUARD QUICK DRY. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Dr. Novis Smith & Co., Inc. (Collingswood, US). The FDA issued a Cleared decision on July 3, 1997 after a review of 476 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6890 - 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 Dr. Novis Smith & Co., Inc. devices

Submission Details

510(k) Number K961044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1996
Decision Date July 03, 1997
Days to Decision 476 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
347d slower than avg
Panel avg: 129d · This submission: 476d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRJ Disinfectant, Medical Devices
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6890
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.