Cleared Traditional

K932277 - LONZA FORMULATION R-82

K932277 is an FDA 510(k) clearance for LONZA FORMULATION R-82, manufactured by Calgon Vestal Div.. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 365-day FDA review.

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

FDA 510(k) Submission Details - K932277

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
236d slower than avg
Panel avg: 129d · This submission: 365d
Pathway characteristics
Predicate-based equivalence.

LRJ Device Classification - Class 1, General Controls

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.

Regulatory Peers - LRJ Disinfectant, Medical Devices

All 16
Devices cleared under the same product code (LRJ) and FDA review panel - the closest regulatory comparables to K932277.
LPH
K931342 · Calgon Vestal Div. · May 1994
VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM
K931816 · Calgon Vestal Div. · May 1994
VESPHENE II
K931573 · Calgon Vestal Div. · May 1994
CIDEX PLUS 28 DAY SOLUTION
K923744 · Johnson & Johnson Medical, Inc. · Mar 1994
CIDEX ACTIVATED DIALDEHYDE SOLUTION
K924434 · Johnson & Johnson Medical, Inc. · Mar 1994
RENALIN COLD STERILANT
K882564 · Minntech Corp. · Jan 1989