Cleared Traditional

K864556 - AQUALUBE(TM) (FDA 510(k) Clearance)

Class I General Hospital device.

K864556 · Parker Laboratories, Inc. · General Hospital
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Dec 1986
Decision
12d
Days
Class 1
Risk

K864556 is an FDA 510(k) clearance for the AQUALUBE(TM). Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Parker Laboratories, Inc. (Orange, US). The FDA issued a Cleared decision on December 1, 1986 after a review of 12 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 Parker Laboratories, Inc. devices

Submission Details

510(k) Number K864556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1986
Decision Date December 01, 1986
Days to Decision 12 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
116d faster than avg
Panel avg: 128d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.