510(k) Report

510(k) · Cleared

Cleared

Vet (Vacuum Erection Technology)

K902240510(k) TraditionalCleared Oct 12, 1990147-day reviewClass II21 CFR 876.5020

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

Vetco, Inc. · LKY Device, External Penile Rigidity

Cleared on Oct 12, 1990 after a 147-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Oct 12, 1990
Review
147 days
Class
Class II
Product code
LKY
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared1997: 1 descendant cleared1990200020102020
  1. This deviceK902240 Vet (Vacuum Erection Technology)Vetco, Inc. · 1990
  2. Descendant · cites it directly · 0 of its ownK990008 Erco-Ribbon -CErcons, Inc. · 1999
  3. Descendant · cites it directly · 0 of its ownK972353 Erco-RibbonErcons, Inc. · 1997

Most influential descendants

Showing 2 of 2 · See all
  • K990008Erco-Ribbon -CErcons, Inc. · 1999 · cites it directly0descendants
  • K972353Erco-RibbonErcons, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K902240Vet (Vacuum Erection Technology)Vetco, Inc.1990—
+1K990008Erco-Ribbon -CErcons, Inc.1999—
+1K972353Erco-RibbonErcons, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
FIG. 1 — Lineage of K902240, 1990–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LKY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K990008Erco-Ribbon -CErcons, Inc.19990
K972353Erco-RibbonErcons, Inc.19970

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K990008 (Ercons, Inc., 1999) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LKY devices

LKY Device, External Penile Rigidity: FDA decisions, review times, recalls and adverse event reports over 20 years.

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

2008: 12013: 12014: 12016: 12017: 22018: 32022: 12023: 2
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20090—00
20100—00
20110—00
20120—00
20130—01
20140—01
20150—00
20160—01
20170—02
20180—03
20190—00
20200—00
20210—00
20220—01
20230—02
20240—00
20250—00
20260—0—
Cite this page

510(k) Report. “K902240: Vet (Vacuum Erection Technology).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K902240

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026