Cleared Traditional

K020586 - GOOD LUBRICATIONS (FDA 510(k) Clearance)

Class I General Hospital device.

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

Submission Details

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
208d slower than avg
Panel avg: 128d · This submission: 336d
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.