Cleared Traditional

K910790 - MENTOR LUBRICATING JELLY

K910790 is an FDA 510(k) clearance for MENTOR LUBRICATING JELLY, manufactured by Mentor Corp.. The device is a Class 1 General Hospital device with product code KMJ cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K910790 · Mentor Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
67d
Days
Class 1
Risk

K910790 is an FDA 510(k) clearance for the MENTOR LUBRICATING JELLY. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Mentor Corp. (Goleta, US). The FDA issued a Cleared decision on May 3, 1991 after a review of 67 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mentor Corp. devices

FDA 510(k) Submission Details - K910790

510(k) Number K910790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1991
Decision Date May 03, 1991
Days to Decision 67 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 129d · This submission: 67d
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 28
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K910790.
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
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