Cleared Traditional

K982985 - CITREX HOSPITAL SPRAY DISINFECTANT

K982985 is an FDA 510(k) clearance for CITREX HOSPITAL SPRAY DISINFECTANT, manufactured by Caltech Industries, Inc.. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K982985 · Caltech Industries, Inc. · General Hospital
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Nov 1998
Decision
68d
Days
Class 1
Risk

K982985 is an FDA 510(k) clearance for the CITREX HOSPITAL SPRAY DISINFECTANT. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Caltech Industries, Inc. (Midland, US). The FDA issued a Cleared decision on November 2, 1998 after a review of 68 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 Caltech Industries, Inc. devices

FDA 510(k) Submission Details - K982985

510(k) Number K982985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1998
Decision Date November 02, 1998
Days to Decision 68 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
61d faster than avg
Panel avg: 129d · This submission: 68d
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 K982985.
AMERSE 2
K983947 · STERIS Corporation · Dec 1998
DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH
K983869 · Caltech Industries, Inc. · Nov 1998
LOW PH PHENOLIC 256
K983585 · Central Solutions, Inc. · Nov 1998
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