Cleared Traditional

K944969 - STERI-LUB LUBRICATION GEL (FDA 510(k) Clearance)

Class I General Hospital device.

K944969 · Horizon Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
139d
Days
Class 1
Risk

K944969 is an FDA 510(k) clearance for the STERI-LUB LUBRICATION GEL. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Horizon Medical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on February 27, 1995 after a review of 139 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 Horizon Medical, Inc. devices

Submission Details

510(k) Number K944969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1994
Decision Date February 27, 1995
Days to Decision 139 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
11d slower than avg
Panel avg: 128d · This submission: 139d
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.