Cleared Traditional

COMFORT PERSONAL LUBRICANT (K915574) - FDA 510(k) Clearance

Class I General Hospital device.

K915574 · Hyman, Phelps & McNamara, P.C. · General Hospital
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Feb 1993
Decision
435d
Days
Class 1
Risk

K915574 is an FDA 510(k) clearance for the COMFORT PERSONAL LUBRICANT. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Hyman, Phelps & McNamara, P.C. (Woodland Hills, US). The FDA issued a Cleared decision on February 19, 1993 after a review of 435 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Hyman, Phelps & McNamara, P.C. devices

Submission Details

510(k) Number K915574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1991
Decision Date February 19, 1993
Days to Decision 435 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
306d slower than avg
Panel avg: 129d · This submission: 435d
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.