Cleared Traditional

K943010 - MAXILUBE

K943010 is an FDA 510(k) clearance for MAXILUBE, manufactured by Mission Pharmacal Co.. The device is a Class 1 General Hospital device with product code KMJ cleared through the Traditional 510(k) pathway after a 390-day FDA review.

K943010 · Mission Pharmacal Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
390d
Days
Class 1
Risk

K943010 is an FDA 510(k) clearance for the MAXILUBE. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Mission Pharmacal Co. (San Antonio, US). The FDA issued a Cleared decision on July 19, 1995 after a review of 390 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Mission Pharmacal Co. devices

FDA 510(k) Submission Details - K943010

510(k) Number K943010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1994
Decision Date July 19, 1995
Days to Decision 390 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
261d slower than avg
Panel avg: 129d · This submission: 390d
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 32
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K943010.
LUBRIGLIDE
K973557 · Qualis, Inc. · Oct 1997
LUBRICATING JELLY, LOW VISCOSITY
K961502 · Span-America Medical Systems, Inc. · Jul 1996
EVRON GEL
K961222 · Pharmaceutical Innovations, Inc. · Jun 1996
ASTROGLIDE
K935299 · Biofilm, Inc. · Feb 1994
MENTOR LUBRICATING JELLY
K910790 · Mentor Corp. · May 1991
MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0
K882506 · Span-America Medical Systems, Inc. · Sep 1988