Cleared Traditional

K940152 - CAMERA COVER WITH TEAR TIP (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K940152 · Hydro-Med Products, Inc. · Gastroenterology & Urology device
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Oct 1994
Decision
298d
Days
Class 1
Risk

K940152 is an FDA 510(k) clearance for the CAMERA COVER WITH TEAR TIP. Classified as Accessories, Photographic, For Endoscope (exclude Light Sources) (product code FEM), Class I - General Controls.

Submitted by Hydro-Med Products, Inc. (Dallas, US). The FDA issued a Cleared decision on October 28, 1994 after a review of 298 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hydro-Med Products, Inc. devices

Submission Details

510(k) Number K940152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1994
Decision Date October 28, 1994
Days to Decision 298 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 130d · This submission: 298d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FEM Accessories, Photographic, For Endoscope (exclude Light Sources)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1500
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.