# K020082: Erecaid Classic System; Erecaid Esteem Manual System; Erecaid Esteem Battery System

- Pathway: 510(k) (Special)
- Applicant: Endocare, Inc.
- Decided: Feb 5, 2002 after 26 days
- Product code: LKY (Device, External Penile Rigidity)
- Device class: 2
- Regulation: 21 CFR 876.5020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Classic and Esteem vacuum systems are intended to artificially produce an erection in males suffering from erectile dysfunction (impotence) in order to facilitate sexual intercourse. A vacuum is applied to the penis, causing it to become erect and rigid as blood is drawn into the corpora cavernosa. A constriction ring is then placed on the base of the penis to restrict venous blood flow out of the penis. The device is intended to be used at home or in a doctor’s office or clinic.

Source page: https://510kreport.com/device/K020082
Methodology: https://510kreport.com/methodology