# K983438: MAX IT

- Pathway: 510(k) (Traditional)
- Applicant: Dorea, Inc.
- Decided: Feb 8, 1999 after 132 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 its predicate without a number.
- (no number) Venous Flow Controller: named in the summary without a submission number

## Indications for use
The Max-Tt device is intended to provide or maintain an erection in men with impotence or premature ejaculation.

Source page: https://510kreport.com/device/K983438
Methodology: https://510kreport.com/methodology