Cleared Traditional

K970825 - BLUE CHIP GERMICIDAL CLEANER & DEODORANT

K970825 is an FDA 510(k) clearance for BLUE CHIP GERMICIDAL CLEANER & DEODORANT, manufactured by S.C. Johnson Professional. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K970825 · S.C. Johnson Professional · General Hospital
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Mar 1997
Decision
8d
Days
Class 1
Risk

K970825 is an FDA 510(k) clearance for the BLUE CHIP GERMICIDAL CLEANER & DEODORANT. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by S.C. Johnson Professional (Racine, US). The FDA issued a Cleared decision on March 14, 1997 after a review of 8 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all S.C. Johnson Professional devices

FDA 510(k) Submission Details - K970825

510(k) Number K970825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1997
Decision Date March 14, 1997
Days to Decision 8 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
121d faster than avg
Panel avg: 129d · This submission: 8d
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 30
Devices cleared under the same product code (LRJ) and FDA review panel - the closest regulatory comparables to K970825.
KLEENASEPTIC
K981023 · Metrex Research Corp. · Apr 1998
T.B.Q. RTU
K980369 · STERIS Corporation · Feb 1998
GERMICIDAL CLOTH
K974304 · Convatec, A Division of E.R. Squibb & Sons · Jan 1998
CIDE-SWIPES P-100B & CIDE-SWIPES C-100A
K964376 · Mp Scientific, Inc. · Dec 1996
VIREX II 128 GERMICIDAL CLEANER AND DEODORANT
K964828 · S.C. Johnson & Son, Inc. · Dec 1996
COVERAGE SPRAY HBV
K964835 · Convatec, A Division of E.R. Squibb & Sons · Dec 1996