Cleared Traditional

LONZA FORMULATION R-82 (K932277) - FDA 510(k) Clearance

Class I General Hospital device.

K932277 · Calgon Vestal Div. · General Hospital
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May 1994
Decision
365d
Days
Class 1
Risk

K932277 is an FDA 510(k) clearance for the LONZA FORMULATION R-82. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Calgon Vestal Div. (Fair Lawn, US). The FDA issued a Cleared decision on May 12, 1994 after a review of 365 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Calgon Vestal Div. devices

Submission Details

510(k) Number K932277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1993
Decision Date May 12, 1994
Days to Decision 365 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
236d slower than avg
Panel avg: 129d · This submission: 365d
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.