Cleared Traditional

K912975 - OPERAND LUBRICATING JELLY

K912975 is an FDA 510(k) clearance for OPERAND LUBRICATING JELLY, manufactured by General Medical Co.. The device is a Class 1 General Hospital device with product code KMJ cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K912975 · General Medical Co. · General Hospital
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Sep 1991
Decision
81d
Days
Class 1
Risk

K912975 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. (Prichard, US). The FDA issued a Cleared decision on September 27, 1991 after a review of 81 days - a notably fast clearance cycle.

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: 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 General Medical Co. devices

FDA 510(k) Submission Details - K912975

510(k) Number K912975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date September 27, 1991
Days to Decision 81 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
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

KMJ Device Classification - Class 1, General Controls

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.

Regulatory Peers - KMJ Lubricant, Patient

All 30
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K912975.
LUBRICATING JELLY, LOW VISCOSITY
K961502 · Span-America Medical Systems, Inc. · Jul 1996
EVRON GEL
K961222 · Pharmaceutical Innovations, Inc. · Jun 1996
ASTROGLIDE
K935299 · Biofilm, Inc. · Feb 1994
MENTOR LUBRICATING JELLY
K910790 · Mentor Corp. · May 1991
MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0
K882506 · Span-America Medical Systems, Inc. · Sep 1988
AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G
K870742 · Span-America Medical Systems, Inc. · Jun 1987