510(k) · Cleared

Cleared

Rigiscan Plus Rigidity Assessment System

K941781510(k) TraditionalCleared Aug 25, 1994136-day reviewClass U

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

Dacomed Corp. · LIL Monitor, Penile Tumescence

Cleared on Aug 25, 1994 after a 136-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: Aug 25, 1994
Review: 136 days
Class: Class U
Product code: LIL
Recalls: None
Predicates: 0

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

This deviceK941781 Rigiscan Plus Rigidity Assessment SystemDacomed Corp. · 1994
Descendant · cites it directly · 0 of its ownK062042 Plethora Solutions Sexual Assessment Monitor (Sam)Plethora Solutions · 2006
Descendant · cites it directly · 0 of its ownK980627 Neva SystemUrometrics, Inc. · 1998

Most influential descendants

Showing 2 of 2 · See all

K062042Plethora Solutions Sexual Assessment Monitor (Sam)Plethora Solutions · 2006 · cites it directly0descendants
K980627Neva SystemUrometrics, Inc. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K941781	Rigiscan Plus Rigidity Assessment System	Dacomed Corp.	1994	—
+1	K062042	Plethora Solutions Sexual Assessment Monitor (Sam)	Plethora Solutions	2006	—
+1	K980627	Neva System	Urometrics, Inc.	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2006	1	0

FIG. 1 — Lineage of K941781, 1994–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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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?

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.

Number	Device	Applicant	Decided	Descendants
K062042	Plethora Solutions Sexual Assessment Monitor (Sam)	Plethora Solutions	2006	0
K980627	Neva System	Urometrics, Inc.	1998	0

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, K062042 (Plethora Solutions, 2006) has gone furthest, with 0 descendants of its own.

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

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

https://510kreport.com/device/K941781 · printed Nov 6, 2026

Cite this page

510(k) Report. “K941781: Rigiscan Plus Rigidity Assessment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941781

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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