FDA product code · Gastroenterology and urology

Device, External Penile Rigidity

Name: FDA decisions, review times, recalls and adverse event reports for product code LKY
Creator: 510(k) Report

LKYClass II21 CFR 876.5020510(k) exempt87 decisions since 19830 recalls

FDA lists LKY as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 876.9 applies, such as a new intended use or a different fundamental technology. 87 FDA decisions since 1983. No recall names this code. The most-cited predicate is K841257, named by 8 later devices.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, gastroenterology and urology panel

Twenty years of LKY at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · LKY

FDA has decided no LKY device since 2007.

Median 510(k) review, days · LKY

Too few LKY 510(k)s in any year since 2007 to give a median.

Recalls per year · LKY

No recall names LKY since 2007.

Adverse event reports per year · LKY

2in 2023

2007high 3 (2018) · low 0 (2007)2025

MAUDE reports naming product code LKY, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	1
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	1
2014	—	1
2015	—	0
2016	—	1
2017	—	2
2018	—	3
2019	—	0
2020	—	0
2021	—	0
2022	—	1
2023	—	2
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — LKY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LKY? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Device, External Penile Rigidity

Which predicates do LKY devices cite most?

Which LKY devices have the deepest lineage?

What has FDA decided in LKY lately?