Cleared Traditional

SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL (K073684) - FDA 510(k) Clearance

Class I General Hospital device.

K073684 · Sheffield Industries, Div. of Faria , Ltd. · General Hospital
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May 2008
Decision
146d
Days
Class 1
Risk

K073684 is an FDA 510(k) clearance for the SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Sheffield Industries, Div. of Faria , Ltd. (New London, US). The FDA issued a Cleared decision on May 22, 2008 after a review of 146 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Sheffield Industries, Div. of Faria , Ltd. devices

Submission Details

510(k) Number K073684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2007
Decision Date May 22, 2008
Days to Decision 146 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
17d slower than avg
Panel avg: 129d · This submission: 146d
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.