Cleared Traditional

K092488 - DYNAREX STERILE LUBRICATING JELLY (FDA 510(k) Clearance)

Class I General Hospital device.

K092488 · Dynarex Corporation · General Hospital
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Dec 2009
Decision
127d
Days
Class 1
Risk

K092488 is an FDA 510(k) clearance for the DYNAREX STERILE LUBRICATING JELLY. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Dynarex Corporation (Orangeburg, US). The FDA issued a Cleared decision on December 18, 2009 after a review of 127 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6375 - 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 Dynarex Corporation devices

Submission Details

510(k) Number K092488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2009
Decision Date December 18, 2009
Days to Decision 127 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 128d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMJ Lubricant, Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6375
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.