Cleared Special

K141028 - COLONGLIDE LUBRICANT

K141028 is an FDA 510(k) clearance for COLONGLIDE LUBRICANT, manufactured by Pediatric Pharmaceuticals, Inc.. The device is a Class 1 General Hospital device with product code KMJ cleared through the Special 510(k) pathway after a 93-day FDA review.

K141028 · Pediatric Pharmaceuticals, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
93d
Days
Class 1
Risk

K141028 is an FDA 510(k) clearance for the COLONGLIDE LUBRICANT. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Pediatric Pharmaceuticals, Inc. (Holmdel, US). The FDA issued a Cleared decision on July 24, 2014 after a review of 93 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K141028

510(k) Number K141028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2014
Decision Date July 24, 2014
Days to Decision 93 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 129d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

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 40
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K141028.
Lubricating Jelly
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DUKAL LUBRICATING JELLY
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STERILE LUBRICATING JELLY
K112110 · Jianerkang Medical Dressing Company · Apr 2012
DYNACOR LUBRICATION GEL
K103718 · Medline Industries, Inc. · May 2011
K141028 · COLONGLIDE LUBRICANT
Download PDF FDA Summary Pediatric Pharmaceuti…