510(k) · Cleared

Cleared

Preftest Professional Suite

K052929510(k) TraditionalCleared Apr 26, 2006189-day reviewClass U

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

Limestone Technologies, Inc. · LIL Monitor, Penile Tumescence

Cleared on Apr 26, 2006 as substantially equivalent to K033126 (Behavioral Technology, Inc., 2003) after a 189-day review. Its family tree reaches back 2 generations to 1995.

Decided: Apr 26, 2006
Review: 189 days
Class: Class U
Product code: LIL
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K936115 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK936115 Cat-600 Penile PlethysmographFarrall Instruments, Inc. · 1995
1 generation backK033126 Monarch 21 Penile Plethysmograph SystemBehavioral Technology, Inc. · 2003
This deviceK052929 Preftest Professional SuiteLimestone Technologies, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K936115	Cat-600 Penile Plethysmograph	Farrall Instruments, Inc.	1995	—
−1	K033126	Monarch 21 Penile Plethysmograph System	Behavioral Technology, Inc.	2003	—
0 (this device)	K052929	Preftest Professional Suite	Limestone Technologies, Inc.	2006	—

FIG. 1 — Lineage of K052929, 1995–2006Source: 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.

Planning a device in LIL? 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

Get a 510(k) Report

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
*	K033126	Monarch 21 Penile Plethysmograph System Summary page 1 …Penile Plethysmograph Classification Name: Monitor, Penile Tumescence Predicate Device Device Name: MONARCH 21 Penile Plethysmograph (K033 126) Description of the Device Limestone Technologies Penile Plethysmograph is based on a circumference measurement using a strain…	Behavioral Technology, Inc.	2003	—

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?

The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
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

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?

The PrefTest Professional SuiteTM is used to measure penile

tumescence in response to visual and auditory stimuli. Penile Tumescence data can

later be combined with other standardized psychological testing procedures to assist

clinicians with their assessment and treatment of sexual offenders.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052929 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052929: Preftest Professional Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052929

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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