Cleared Traditional

K850019 - OMNI PHASE PENILE PROSTHESIS

K850019 is the FDA 510(k) clearance for OMNI PHASE PENILE PROSTHESIS by Dacomed Corp.. It is a Class 2 Gastroenterology & Urology device (product code FAE) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K850019 · Dacomed Corp. · Gastroenterology & Urology device
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Apr 1985
Decision
96d
Days
Class 2
Risk

K850019 is an FDA 510(k) clearance for the OMNI PHASE PENILE PROSTHESIS. Classified as Prosthesis, Penile (product code FAE), Class II - Special Controls.

Submitted by Dacomed Corp. (Minneapolis, US). The FDA issued a Cleared decision on April 9, 1985 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.3630 - 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 Dacomed Corp. devices

Submission Details

510(k) Number K850019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1985
Decision Date April 09, 1985
Days to Decision 96 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 130d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAE Prosthesis, Penile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.3630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FAE Prosthesis, Penile

All 19
Devices cleared under the same product code (FAE) and FDA review panel - the closest regulatory comparables to K850019.
MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE)
K890402 · Mentor Corp. · Aug 1989
BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS
K864040 · C.R. Bard, Inc. · Oct 1986
MENTOR CORPORAL DILATORS
K860517 · Mentor Corp. · Mar 1986
MALLEABLE PENILE PROSTHESIS
K843280 · Mentor Corp. · Oct 1984
AMS MALLEABLE PENILE PROSTHESIS
K831660 · American Medical Systems, Inc. · Aug 1983
INFLATABLE PENILE PROSTH. - CYLINDER
K830048 · American Medical Systems, Inc. · Apr 1983