Cleared Traditional

K830048 - INFLATABLE PENILE PROSTH. - CYLINDER

K830048 is an FDA 510(k) clearance for INFLATABLE PENILE PROSTH. - CYLINDER, manufactured by American Medical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAE cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K830048 · American Medical Systems, Inc. · Gastroenterology & Urology device
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Apr 1983
Decision
92d
Days
Class 2
Risk

K830048 is an FDA 510(k) clearance for the INFLATABLE PENILE PROSTH. - CYLINDER. Classified as Prosthesis, Penile (product code FAE), Class II - Special Controls.

Submitted by American Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 12, 1983 after a review of 92 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 American Medical Systems, Inc. devices

FDA 510(k) Submission Details - K830048

510(k) Number K830048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1983
Decision Date April 12, 1983
Days to Decision 92 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 131d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAE Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (FAE) and FDA review panel - the closest regulatory comparables to K830048.
ESKA JONAS SILICON-SILVER PENILE
K834504 · Dacomed Corp. · Feb 1984
SURGIKEK PENILE PROSTHESIS TAIL EXTEND
K832043 · Medical Engineering Corp. · Oct 1983
AMS MALLEABLE PENILE PROSTHESIS
K831660 · American Medical Systems, Inc. · Aug 1983
SURGITEK SIZER FOR PENILE PROSTHESIS
K830917 · Medical Engineering Corp. · Apr 1983
THE INFLATABLE PENILE PROSTHESIS
K821628 · American Medical Systems, Inc. · Aug 1982
ESKA JONAS SILICONE-SILVER PENILE PROST
K820081 · Dacomed Corp. · Jan 1982