# K030913: Nanma Vacuum Pump

- Pathway: 510(k) (Traditional)
- Applicant: Nanma Mfg Co., Ltd.
- Decided: Jun 3, 2003 after 71 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Nanma Vacuum Pumps are external penile rigidity devices designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pumps are used to create er erections in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)

Source page: https://510kreport.com/device/K030913
Methodology: https://510kreport.com/methodology