Cleared Traditional

K961502 - LUBRICATING JELLY

K961502 is the FDA 510(k) clearance for LUBRICATING JELLY by Span-America Medical Systems, Inc.. It is a Class 1 General Hospital device (product code KMJ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K961502 · Span-America Medical Systems, Inc. · General Hospital
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Jul 1996
Decision
90d
Days
Class 1
Risk

K961502 is an FDA 510(k) clearance for the LUBRICATING JELLY, LOW VISCOSITY. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Span-America Medical Systems, Inc. (Greenville, US). The FDA issued a Cleared decision on July 18, 1996 after a review of 90 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 Span-America Medical Systems, Inc. devices

Submission Details

510(k) Number K961502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1996
Decision Date July 18, 1996
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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.

Regulatory Peers - KMJ Lubricant, Patient

All 8
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K961502.
DYNACOR LUBRICATION GEL
K103718 · Medline Industries, Inc. · May 2011
MENTOR LUBRICATING JELLY
K910790 · Mentor Corp. · May 1991
STERILE SALINE SOLUTION
K854155 · I M, Inc. · Dec 1985
TOMAC LUBRICATING JELLY
K822143 · American Medical Systems, Inc. · Jul 1982
WET PACK LINE OF PRODUCTS
K820587 · Abco Dealers, Inc. · Mar 1982
K-Y LUBRICATING JELLY
K810310 · Johnson & Johnson Professionals, Inc. · Apr 1981