Cleared Traditional

K101522 - ULTRA SEAL STERILE LUBRICATING JELLY

K101522 is an FDA 510(k) clearance for ULTRA SEAL STERILE LUBRICATING JELLY, manufactured by Ultra Seal Corporation. The device is a Class 1 General Hospital device with product code KMJ cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K101522 · Ultra Seal Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
204d
Days
Class 1
Risk

K101522 is an FDA 510(k) clearance for the ULTRA SEAL STERILE LUBRICATING JELLY. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Ultra Seal Corporation (New Paltz, US). The FDA issued a Cleared decision on December 23, 2010 after a review of 204 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.

FDA 510(k) Submission Details - K101522

510(k) Number K101522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2010
Decision Date December 23, 2010
Days to Decision 204 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
75d slower than avg
Panel avg: 129d · This submission: 204d
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 K101522.
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
DYNAREX STERILE LUBRICATING JELLY
K092488 · Dynarex Corporation · Dec 2009
STERI-LUB LUBRICATION GEL
K083189 · Avail Medical Products, Inc. · Nov 2008
SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL
K073684 · Sheffield Industries, Div. of Faria , Ltd. · May 2008
K101522 · ULTRA SEAL STERILE LUBRICATING JELLY
Download PDF FDA Summary Ultra Seal Corporation