Cleared Traditional

K853653 - SANA-LUBE

K853653 is an FDA 510(k) clearance for SANA-LUBE, manufactured by Huntington Laboratories, Inc.. The device is a Class 1 General Hospital device with product code KMJ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K853653 · Huntington Laboratories, Inc. · General Hospital
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Nov 1985
Decision
71d
Days
Class 1
Risk

K853653 is an FDA 510(k) clearance for the SANA-LUBE. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Huntington Laboratories, Inc. (Huntington, US). The FDA issued a Cleared decision on November 13, 1985 after a review of 71 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 Huntington Laboratories, Inc. devices

FDA 510(k) Submission Details - K853653

510(k) Number K853653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1985
Decision Date November 13, 1985
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
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 27
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K853653.
AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G
K870742 · Span-America Medical Systems, Inc. · Jun 1987
AQUALUBE(TM)
K864556 · Parker Laboratories, Inc. · Dec 1986
STERILE SALINE SOLUTION
K854155 · I M, Inc. · Dec 1985
TOMAC LUBRICATING JELLY
K822143 · American Medical Systems, Inc. · Jul 1982
WET PACK LINE OF PRODUCTS
K820587 · Abco Dealers, Inc. · Mar 1982
A.D.T. PROCEDURES TRAY
K812297 · A.D.T. Lab Industries · Sep 1981