Cleared Traditional

K803111 - ERECTAID

K803111 is the FDA 510(k) clearance for ERECTAID by Burditt & Calkins-Siemens-Elema. It is a Class 2 Gastroenterology & Urology device (product code FAE) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K803111 · Burditt & Calkins-Siemens-Elema · Gastroenterology & Urology device
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Jan 1981
Decision
44d
Days
Class 2
Risk

K803111 is an FDA 510(k) clearance for the ERECTAID. Classified as Prosthesis, Penile (product code FAE), Class II - Special Controls.

Submitted by Burditt & Calkins-Siemens-Elema (Chicago, US). The FDA issued a Cleared decision on January 23, 1981 after a review of 44 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 Burditt & Calkins-Siemens-Elema devices

Submission Details

510(k) Number K803111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1980
Decision Date January 23, 1981
Days to Decision 44 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
86d faster than avg
Panel avg: 130d · This submission: 44d
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 14
Devices cleared under the same product code (FAE) and FDA review panel - the closest regulatory comparables to K803111.
AMS MALLEABLE PENILE PROSTHESIS
K831660 · American Medical Systems, Inc. · Aug 1983
INFLATABLE PENILE PROSTH. - CYLINDER
K830048 · American Medical Systems, Inc. · Apr 1983
THE INFLATABLE PENILE PROSTHESIS
K821628 · American Medical Systems, Inc. · Aug 1982
AMS MALLEABLE OR JONAS SILICONE-SILVER
K792724 · American Medical Systems, Inc. · Sep 1980