Cleared Traditional

K113689 - DUKAL LUBRICATING JELLY

K113689 is an FDA 510(k) clearance for DUKAL LUBRICATING JELLY, manufactured by Dukal Corporation. The device is a Class 1 General Hospital device with product code KMJ cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K113689 · Dukal Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
141d
Days
Class 1
Risk

K113689 is an FDA 510(k) clearance for the DUKAL LUBRICATING JELLY. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Dukal Corporation (Ronkonkoma, US). The FDA issued a Cleared decision on May 4, 2012 after a review of 141 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 Dukal Corporation devices

FDA 510(k) Submission Details - K113689

510(k) Number K113689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2011
Decision Date May 04, 2012
Days to Decision 141 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
12d slower than avg
Panel avg: 129d · This submission: 141d
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 10
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K113689.
DYNACOR LUBRICATION GEL
K103718 · Medline Industries, Inc. · May 2011
MENTOR LUBRICATING JELLY
K910790 · Mentor Corp. · May 1991
AQUALUBE(TM)
K864556 · Parker Laboratories, Inc. · Dec 1986
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