Cleared Traditional

K142473 - Lubricating Jelly (FDA 510(k) Clearance)

Class I General Hospital device.

K142473 · Sion Biotext Medical , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
222d
Days
Class 1
Risk

K142473 is an FDA 510(k) clearance for the Lubricating Jelly. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Sion Biotext Medical , Ltd. (Upper Galilee, IL). The FDA issued a Cleared decision on April 13, 2015 after a review of 222 days - an extended review cycle.

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 Sion Biotext Medical , Ltd. devices

Submission Details

510(k) Number K142473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2014
Decision Date April 13, 2015
Days to Decision 222 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
94d slower than avg
Panel avg: 128d · This submission: 222d
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.