# K981357: Erco-Vac

- Pathway: 510(k) (Traditional)
- Applicant: Ercons, Inc.
- Decided: Nov 24, 1998 after 224 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
Longest line of descent: 1 generation back to K841257 (1984). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K841257: Sta-Potent System, Nu-Potent (1984) Summary page 1.
- K901223: Vacuum Erection Device (Ved), Mission Pharmacal Co. (1990) Summary page 1.
- K960828: Pos-T-Vac B-10 Band Kit, Pos-T-Vac, Inc. (1996) Summary page 1.
- K960342: Pos-T-Vac Avp-1000 & MVP-700, Pos-T-Vac, Inc. (1996) Summary page 1.

## Most influential descendants
- K990006: Erco-Vac -C (1999), 0 descendants of its own

## Indications for use
Erco-Vac M is used to create an erection in men with erectile dysfunction. Erco-Vac M can be used for patients with following conditions: Diabetes Venous leakage Prostatectomy Hypertension Psychogenic impotence Impotence due to radiation therapy Spinal cord injury

Source page: https://510kreport.com/device/K981357
Methodology: https://510kreport.com/methodology