# K981180: Rejoyn Constriction Ring Kit, Pos-T-Vac B-100 Ring Kit, Pos-T-Vac B-25 Ring Kit and Pos-T-Vac B-10 Ring Kit

- Pathway: 510(k) (Traditional)
- Applicant: Pos-T-Vac, Inc.
- Decided: Aug 28, 1998 after 149 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K993343: Erecxel Adjustable Penile Bands, Contrex Adjustable Penile Bands (2000), 0 descendants of its own

## Indications for use
All four sets of constriction rings, the Rejoyn Constriction Ring Kit, B-100, B-25, and B-10, are used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection (either with the aid of a vacuum pump, or naturally). The constriction band is placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.

Source page: https://510kreport.com/device/K981180
Methodology: https://510kreport.com/methodology