Cleared Traditional

K964376 - CIDE-SWIPES P-100B & CIDE-SWIPES C-100A

K964376 is an FDA 510(k) clearance for CIDE-SWIPES P-100B & CIDE-SWIPES C-100A, manufactured by Mp Scientific, Inc.. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K964376 · Mp Scientific, Inc. · General Hospital
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Dec 1996
Decision
52d
Days
Class 1
Risk

K964376 is an FDA 510(k) clearance for the CIDE-SWIPES P-100B & CIDE-SWIPES C-100A. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Mp Scientific, Inc. (Seaford, US). The FDA issued a Cleared decision on December 23, 1996 after a review of 52 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 Mp Scientific, Inc. devices

FDA 510(k) Submission Details - K964376

510(k) Number K964376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1996
Decision Date December 23, 1996
Days to Decision 52 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
77d faster than avg
Panel avg: 129d · This submission: 52d
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 K964376.
T.B.Q. RTU
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K974304 · Convatec, A Division of E.R. Squibb & Sons · Jan 1998
BLUE CHIP GERMICIDAL CLEANER & DEODORANT
K970825 · S.C. Johnson Professional · Mar 1997
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
VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT
K964535 · S.C. Johnson & Son, Inc. · Dec 1996