Cleared Traditional

K020586 - GOOD LUBRICATIONS

K020586 is an FDA 510(k) clearance for GOOD LUBRICATIONS, manufactured by Biofilm, Inc.. The device is a Class 1 General Hospital device with product code KMJ cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K020586 · Biofilm, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
336d
Days
Class 1
Risk

K020586 is an FDA 510(k) clearance for the GOOD LUBRICATIONS. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Biofilm, Inc. (Vista, US). The FDA issued a Cleared decision on January 24, 2003 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Biofilm, Inc. devices

FDA 510(k) Submission Details - K020586

510(k) Number K020586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2002
Decision Date January 24, 2003
Days to Decision 336 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 129d · This submission: 336d
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 11
Devices cleared under the same product code (KMJ) and FDA review panel - the closest regulatory comparables to K020586.
DYNACOR LUBRICATION GEL
K103718 · Medline Industries, Inc. · May 2011
MENTOR LUBRICATING JELLY
K910790 · Mentor Corp. · May 1991
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