Cleared Traditional

K964835 - COVERAGE SPRAY HBV

K964835 is an FDA 510(k) clearance for COVERAGE SPRAY HBV, manufactured by Convatec, A Division of E.R. Squibb & Sons. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K964835 · Convatec, A Division of E.R. Squibb & Sons · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
21d
Days
Class 1
Risk

K964835 is an FDA 510(k) clearance for the COVERAGE SPRAY HBV. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (St. Louis, US). The FDA issued a Cleared decision on December 16, 1996 after a review of 21 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 Convatec, A Division of E.R. Squibb & Sons devices

FDA 510(k) Submission Details - K964835

510(k) Number K964835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1996
Decision Date December 16, 1996
Days to Decision 21 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 129d · This submission: 21d
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 37
Devices cleared under the same product code (LRJ) and FDA review panel - the closest regulatory comparables to K964835.
BLUE CHIP GERMICIDAL CLEANER & DEODORANT
K970825 · S.C. Johnson Professional · Mar 1997
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
VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT
K964535 · S.C. Johnson & Son, Inc. · Dec 1996
TRIAD II DISINFECTANT CLEANER AND DEODORANT
K964610 · S.C. Johnson & Son, Inc. · Dec 1996
VIREX II 256 GERMICIDAL CLEANER AND DEODORANT
K964613 · S.C. Johnson & Son, Inc. · Dec 1996