Cleared Traditional

K900110 - OPERAND* LUBRICATING JELLY (FDA 510(k) Clearance)

Class I General Hospital device.

K900110 · General Medical Co. · General Hospital
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May 1990
Decision
113d
Days
Class 1
Risk

K900110 is an FDA 510(k) clearance for the OPERAND* LUBRICATING JELLY. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by General Medical Co. (Richmond, US). The FDA issued a Cleared decision on May 2, 1990 after a review of 113 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 General Medical Co. devices

Submission Details

510(k) Number K900110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1990
Decision Date May 02, 1990
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 128d · This submission: 113d
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.