

# LIL · Monitor, Penile Tumescence

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/productcode/LIL

## Overview

- **Product Code:** LIL
- **Device Name:** Monitor, Penile Tumescence
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (20 of 26)

Showing 20 most recent of 26 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K061676](/device/K061676.md) | RIGIDOMETER, MODEL DIR-4U | Uroan 21 | Dec 27, 2006 | SESE |
| [K062042](/device/K062042.md) | PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) | Plethora Solutions | Sep 6, 2006 | SESE |
| [K052929](/device/K052929.md) | PREFTEST PROFESSIONAL SUITE | Limestone Technologies, Inc. | Apr 26, 2006 | SESE |
| [K033126](/device/K033126.md) | MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM | Behavioral Technology, Inc. | Oct 29, 2003 | SESE |
| [K000194](/device/K000194.md) | DIGITAL INFLECTION RIGIDOMETER (DIR) | Uroan Xxi Electromedicina | Apr 10, 2000 | SESE |
| [K991479](/device/K991479.md) | VISER PENILE TUMESCENCE MONITOR | Laborie Medical Tech Corp. | Jul 7, 1999 | SESE |
| [K980627](/device/K980627.md) | NEVA SYSTEM | Urometrics, Inc. | Apr 7, 1998 | SESE |
| [K940128](/device/K940128.md) | CAT-400UL PENILE PLETHYSMOGRAPH | Farrall Instruments, Inc. | Jan 10, 1995 | SESE |
| [K936115](/device/K936115.md) | CAT-600 PENILE PLETHYSMOGRAPH | Farrall Instruments, Inc. | Jan 10, 1995 | SESE |
| [K941781](/device/K941781.md) | RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM | Dacomed Corp. | Aug 25, 1994 | SESE |
| [K925931](/device/K925931.md) | RT2 RIGIDITY AND TUMESCENCE TEST | Compass Medical Technologies, Inc. | Dec 21, 1992 | SESE |
| [K880903](/device/K880903.md) | BARD (R) ESKA ERECTIOMETER | C.R. Bard, Inc. | May 6, 1988 | SESE |
| [K875333](/device/K875333.md) | SURGITEK NPT MONITOR | Surgitek | Apr 13, 1988 | SESE |
| [K870983](/device/K870983.md) | NOCTURNAL PENILE TUMESCENCE MONITOR | Texas Medical Electronics Co. | Jun 23, 1987 | SESE |
| [K851646](/device/K851646.md) | VIBRECTOR | Multicept, Aps. | Aug 21, 1985 | SESE |
| [K841879](/device/K841879.md) | LFT - 212 | Medical Monitoring Systems, Inc. | Jul 26, 1984 | SESE |
| [K841202](/device/K841202.md) | DACOMED RIGISCAN SYSTEM | Dacomed Corp. | Jul 6, 1984 | SESE |
| [K833454](/device/K833454.md) | BIOREM 3000 & 4000 | Biorem | Feb 21, 1984 | SESE |
| [K832121](/device/K832121.md) | DACOMED SNAP-GAUGE | Dacomed Corp. | Jul 18, 1983 | SESE |
| [K831251](/device/K831251.md) | TUMISENSOR 1524 | Life-Tech Intl., Inc. | Jun 3, 1983 | SESE |

## Top Applicants

- Dacomed Corp. — 4 clearances
- Biorem — 2 clearances
- Farrall Instruments, Inc. — 2 clearances
- Life-Tech Intl., Inc. — 2 clearances
- Medical Monitoring Systems, Inc. — 2 clearances

---

**Source:** [https://fda.innolitics.com/productcode/LIL](https://fda.innolitics.com/productcode/LIL)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
