510(k) · Cleared

Cleared

Neva System

K980627510(k) TraditionalCleared Apr 7, 199848-day reviewClass U

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

Urometrics, Inc. · LIL Monitor, Penile Tumescence

Cleared on Apr 7, 1998 as substantially equivalent to K941781 (Dacomed Corp., 1994) after a 48-day review. Its family tree reaches back 1 generation to 1994.

Decided: Apr 7, 1998
Review: 48 days
Class: Class U
Product code: LIL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K941781 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK941781 Rigiscan Plus Rigidity Assessment SystemDacomed Corp. · 1994
This deviceK980627 Neva SystemUrometrics, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K941781	Rigiscan Plus Rigidity Assessment System	Dacomed Corp.	1994	—
0 (this device)	K980627	Neva System	Urometrics, Inc.	1998	—

FIG. 1 — Lineage of K980627, 1994–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K941781	Rigiscan Plus Rigidity Assessment System Summary page 2 …itor Penile Tumescence Monitor 78 LIL [} None K4506LAT ad 5 C. Identification of Legally Marketed Device 1. Name: RigiScan® Plus System 2. K Number: K941781 3. Date Cleared: August 25, 1994 D. Description of the Device The UroMetrics NEVA system consists of three disposable electrode…	Dacomed Corp.	1994	—

Also cleared against K941781: 1 other device →

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?

Its one ancestor has no recall.
1 other device also cites its predicate K941781.

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	—	—

What is it indicated for?

Measure and record penile erectile events nocturnally

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980627 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980627: Neva System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980627

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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