510(k) Report

510(k) · Cleared

Cleared

Plethora Solutions Sexual Assessment Monitor (Sam)

K062042510(k) TraditionalCleared Sep 6, 200649-day reviewClass U

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

Plethora Solutions · LIL Monitor, Penile Tumescence

Cleared on Sep 6, 2006 as substantially equivalent to K841202 (Dacomed Corp., 1984) and 1 other predicate after a 49-day review. Its family tree reaches back 1 generation to 1984.

Decided
Sep 6, 2006
Review
49 days
Class
Class U
Product code
LIL
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K841202 (1984). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestorK841202 · Dacomed Rigiscan System · Dacomed Corp. · 1984198019851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K841202 · Dacomed Rigiscan System · Dacomed Corp. · 19840
  1. Root · 1 generation backK841202 Dacomed Rigiscan SystemDacomed Corp. · 1984
  2. This deviceK062042 Plethora Solutions Sexual Assessment Monitor (Sam)Plethora Solutions · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K841202Dacomed Rigiscan SystemDacomed Corp.1984—
0 (this device)K062042Plethora Solutions Sexual Assessment Monitor (Sam)Plethora Solutions2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
FIG. 1 — Lineage of K062042, 1984–2006Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • 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? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K841202Dacomed Rigiscan System
Summary page 1
…Manufacturer Device Name 510-K Number Decision Date Dacomed Corporation Rigiscan System K841202 07/06/1984 Dacomed Corporation Rigiscan Plus Rigidity K941781 08/25/1994…
Dacomed Corp.1984—
*K941781Rigiscan Plus Rigidity Assessment System
Summary page 1
…Dacomed Corporation Rigiscan System K841202 07/06/1984 Dacomed Corporation Rigiscan Plus Rigidity K941781 08/25/1994 Assessment System D). Device Description:…
Dacomed Corp.1994—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All LIL devices

LIL Monitor, Penile Tumescence: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LIL

FDA has decided no LIL device since 2007.

Median 510(k) review, days · LIL

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

Recalls per year · LIL

No recall names LIL since 2007.

Adverse event reports per year · LIL

No MAUDE report names LIL since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Plethora Solutions Sexual Assessment Monitor (SAM) is intended for use as a diagnostic tool for use in the quantifiable assessment and monitoring of penile

tumescence and ejaculatory latency.

Indications for use as stated in the FDA summary.

Recent decisions in LIL

The LIL category page

  • K061676Rigidometer, Model Dir-4UUroan 21 · 2006
  • K052929Preftest Professional SuiteLimestone Technologies, Inc. · 2006
  • K033126Monarch 21 Penile Plethysmograph SystemBehavioral Technology, Inc. · 2003
  • K000194Digital Inflection Rigidometer (Dir)Uroan Xxi Electromedicina · 2000
  • K991479Viser Penile Tumescence MonitorLaborie Medical Tech Corp. · 1999

https://510kreport.com/device/K062042 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062042: Plethora Solutions Sexual Assessment Monitor (Sam).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062042

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026