Cleared Traditional

K131617 - COLONGLIDE(R) LUBRICANT (FDA 510(k) Clearance)

Class I General Hospital device.

K131617 · Pediatric Pharmaceuticals, Inc. · General Hospital
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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.

View all Pediatric Pharmaceuticals, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 129d · This submission: 122d
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.