Cleared Traditional

K791970 - HYGENIC RUBBER DAM LUBRICANT

K791970 is an FDA 510(k) clearance for HYGENIC RUBBER DAM LUBRICANT, manufactured by The Hygenic Corp.. The device is a Class 1 General Hospital device with product code KMJ cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K791970 · The Hygenic Corp. · General Hospital
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Nov 1979
Decision
45d
Days
Class 1
Risk

K791970 is an FDA 510(k) clearance for the HYGENIC RUBBER DAM LUBRICANT. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by The Hygenic Corp. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1979 after a review of 45 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 The Hygenic Corp. devices

FDA 510(k) Submission Details - K791970

510(k) Number K791970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1979
Decision Date November 16, 1979
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 129d · This submission: 45d
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 31
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K791970.
A.D.T. PROCEDURES TRAY
K812297 · A.D.T. Lab Industries · Sep 1981
PEDICAT*
K810049 · Pollak (Intl.), Ltd. · Apr 1981
K-Y LUBRICATING JELLY
K810310 · Johnson & Johnson Professionals, Inc. · Apr 1981
LUBRICATING JELLY
K791243 · Abco Dealers, Inc. · Aug 1979
PRESERVE LUBRICANT CODE NO. 43=4035
K770498 · Codman & Shurtleff, Inc. · Jun 1977