Cleared Traditional

K103718 - DYNACOR LUBRICATION GEL

K103718 is the FDA 510(k) clearance for DYNACOR LUBRICATION GEL by Medline Industries, Inc.. It is a Class 1 General Hospital device (product code KMJ) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K103718 · Medline Industries, Inc. · General Hospital
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May 2011
Decision
140d
Days
Class 1
Risk

K103718 is an FDA 510(k) clearance for the DYNACOR LUBRICATION GEL. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on May 10, 2011 after a review of 140 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K103718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2010
Decision Date May 10, 2011
Days to Decision 140 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 129d · This submission: 140d
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

Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K103718.
MENTOR LUBRICATING JELLY
K910790 · Mentor Corp. · May 1991
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
LUBRICATING JELLY
K791243 · Abco Dealers, Inc. · Aug 1979
PRESERVE LUBRICANT CODE NO. 43=4035
K770498 · Codman & Shurtleff, Inc. · Jun 1977