Cleared Traditional

K131617 - COLONGLIDE(R) LUBRICANT

K131617 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 Traditional 510(k) pathway after a 122-day FDA review.

K131617 · Pediatric Pharmaceuticals, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
122d
Days
Class 1
Risk

K131617 is an FDA 510(k) clearance for the COLONGLIDE(R) 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 October 3, 2013 after a review of 122 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.

FDA 510(k) Submission Details - K131617

510(k) Number K131617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2013
Decision Date October 03, 2013
Days to Decision 122 days
Submission Type Traditional
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
7d faster than avg
Panel avg: 129d · This submission: 122d
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 40
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K131617.
Lubricating Jelly
K142473 · Sion Biotext Medical , Ltd. · Apr 2015
COLONGLIDE LUBRICANT
K141028 · Pediatric Pharmaceuticals, Inc. · Jul 2014
LUBE JELLY SURINGE
K121390 · Nurse Assist, Inc. · Aug 2012
DUKAL LUBRICATING JELLY
K113689 · Dukal Corporation · May 2012
STERILE LUBRICATING JELLY
K112110 · Jianerkang Medical Dressing Company · Apr 2012
DYNACOR LUBRICATION GEL
K103718 · Medline Industries, Inc. · May 2011
K131617 · COLONGLIDE(R) LUBRICANT
Download PDF FDA Summary Pediatric Pharmaceuti…