Cleared Traditional

K821628 - THE INFLATABLE PENILE PROSTHESIS

K821628 is an FDA 510(k) clearance for THE INFLATABLE PENILE PROSTHESIS, 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 69-day FDA review.

K821628 · American Medical Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1982
Decision
69d
Days
Class 2
Risk

K821628 is an FDA 510(k) clearance for the THE INFLATABLE PENILE PROSTHESIS. 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 August 10, 1982 after a review of 69 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Medical Systems, Inc. devices

FDA 510(k) Submission Details - K821628

510(k) Number K821628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1982
Decision Date August 10, 1982
Days to Decision 69 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
62d faster than avg
Panel avg: 131d · This submission: 69d
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 K821628.
AMS MALLEABLE PENILE PROSTHESIS
K831660 · American Medical Systems, Inc. · Aug 1983
INFLATABLE PENILE PROSTH. - CYLINDER
K830048 · American Medical Systems, Inc. · Apr 1983
SURGITEK SIZER FOR PENILE PROSTHESIS
K830917 · Medical Engineering Corp. · Apr 1983
ESKA JONAS SILICONE-SILVER PENILE PROST
K820081 · Dacomed Corp. · Jan 1982
AMS MALLEABLE OR JONAS SILICONE-SILVER
K792724 · American Medical Systems, Inc. · Sep 1980