Cleared Traditional

K791243 - LUBRICATING JELLY

K791243 is an FDA 510(k) clearance for LUBRICATING JELLY, manufactured by Abco Dealers, Inc.. The device is a Class 1 General Hospital device with product code KMJ cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K791243 · Abco Dealers, Inc. · General Hospital
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Aug 1979
Decision
25d
Days
Class 1
Risk

K791243 is an FDA 510(k) clearance for the LUBRICATING JELLY. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 25 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.

FDA 510(k) Submission Details - K791243

510(k) Number K791243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1979
Decision Date August 03, 1979
Days to Decision 25 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
104d faster than avg
Panel avg: 129d · This submission: 25d
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 48
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K791243.
PEDICAT*
K810049 · Pollak (Intl.), Ltd. · Apr 1981
K-Y LUBRICATING JELLY
K810310 · Johnson & Johnson Professionals, Inc. · Apr 1981
HYGENIC RUBBER DAM LUBRICANT
K791970 · The Hygenic Corp. · Nov 1979
LUBRICANT, OTRHO PERSONAL
K790087 · Ortho Pharmaceutical Corp. · Feb 1979
PRESERVE LUBRICANT CODE NO. 43=4035
K770498 · Codman & Shurtleff, Inc. · Jun 1977
K791243 · LUBRICATING JELLY
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