Cleared Traditional

K960836 - DMS-9000

K960836 is an FDA 510(k) clearance for DMS-9000, manufactured by O.R. Solutions, Inc.. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K960836 · O.R. Solutions, Inc. · General Hospital
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Sep 1996
Decision
196d
Days
Class 1
Risk

K960836 is an FDA 510(k) clearance for the DMS-9000. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by O.R. Solutions, Inc. (Chantilly, US). The FDA issued a Cleared decision on September 12, 1996 after a review of 196 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 O.R. Solutions, Inc. devices

FDA 510(k) Submission Details - K960836

510(k) Number K960836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 1996
Decision Date September 12, 1996
Days to Decision 196 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 129d · This submission: 196d
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 12
Devices cleared under the same product code (LRJ) and FDA review panel - the closest regulatory comparables to K960836.
COVERAGE SPRAY HBV
K964835 · Convatec, A Division of E.R. Squibb & Sons · Dec 1996
COVERAGE HBV
K964749 · Convatec, A Division of E.R. Squibb & Sons · Dec 1996
T.B.Q.
K962739 · Convatec, A Division of E.R. Squibb & Sons · Oct 1996
VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT
K934014 · Biotrol, USA, Inc. · Dec 1995
RENALIN COLD STERILANT
K941439 · Minntech Corp. · Jun 1995
CIDEX PLUS 28 DAY SOLUTION
K923744 · Johnson & Johnson Medical, Inc. · Mar 1994