Cleared Traditional

K142473 - Lubricating Jelly

K142473 is an FDA 510(k) clearance for Lubricating Jelly, manufactured by Sion Biotext Medical , Ltd.. The device is a Class 1 General Hospital device with product code KMJ cleared through the Traditional 510(k) pathway after a 222-day FDA review.

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

FDA 510(k) Submission Details - K142473

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
93d slower than avg
Panel avg: 129d · This submission: 222d
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 14
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K142473.
DYNACOR LUBRICATION GEL
K103718 · Medline Industries, Inc. · May 2011
LUBRICATING JELLY, LOW VISCOSITY
K961502 · Span-America Medical Systems, Inc. · Jul 1996
MENTOR LUBRICATING JELLY
K910790 · Mentor Corp. · May 1991
MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0
K882506 · Span-America Medical Systems, Inc. · Sep 1988
AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G
K870742 · Span-America Medical Systems, Inc. · Jun 1987
AQUALUBE(TM)
K864556 · Parker Laboratories, Inc. · Dec 1986