LKYClass II

Device, External Penile Rigidity

21 CFR 876.5020 / Gastroenterology, Urology

LKY is the FDA product code for Device, External Penile Rigidity, a class II device type, regulated under 21 CFR 876.5020. FDA's definition for this code reads: "Intended to create or maintain sufficient penile rigidity for sexual intercourse. These include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered or pneumatic devices". As of 2026-09-10, FDA records hold 87 510(k) clearances under this code, the most recent dated 2004-08-25, and no recalls.

Classification record

Product code: LKY
Device name: Device, External Penile Rigidity
FDA definition: Intended to create or maintain sufficient penile rigidity for sexual intercourse. These include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered or pneumatic devices.
Regulation: 21 CFR 876.5020
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 87
Ingested recalls: 0

Clearances, product code LKY

By decision year

87 clearances under product code LKY with a decision year between 1983 and 2004, 1998 the highest year at 17.

Show the numbers

510(k) clearances under FDA product code LKY by decision year
Year	Clearances
1983	2
1984	1
1985	1
1986	1
1987	1
1988	2
1989	2
1990	11
1991	3
1992	2
1994	3
1996	4
1997	6
1998	17
1999	6
2000	7
2001	7
2002	7
2003	3
2004	1

Applicants with the most clearances

Product code LKY

Applicants holding the most 510(k) clearances under product code LKY
Applicant	Clearances
Pos-T-Vac, LLC	11
Nanma Mfg Co., Ltd.	9
Ercons, Inc.	6
Vts, Inc.	5
Walling Medical Equipment Co.	4
Dacomed Corp.	2
Imagyn Medical Technologies, Inc.	2
Numedtec, Inc.	2
Osbon Medical Systems, Ltd.	2
Owen Mumford USA, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order