Monitor, Penile Tumescence
A penile tumescence monitor is a device used to assess nocturnal penile tumescence (NPT) by measuring and recording spontaneous erections during sleep, providing diagnostic information relevant to the evaluation of erectile dysfunction and distinguishing organic from psychogenic causes. This device is currently unclassified by the FDA, meaning a formal risk classification has not been established. It carries product code LIL and no regulation number or medical specialty has been assigned. No special flags apply to this device.
Basic Information
- Product Code
- LIL
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 26 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K061676 | RIGIDOMETER, MODEL DIR-4U | Dec 27, 2006 | Substantially Equivalent | UROAN 21 |
| K062042 | PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) | Sep 06, 2006 | Substantially Equivalent | PLETHORA SOLUTIONS |
| K052929 | PREFTEST PROFESSIONAL SUITE | Apr 26, 2006 | Substantially Equivalent | LIMESTONE TECHNOLOGIES INC. |
| K033126 | MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM | Oct 29, 2003 | Substantially Equivalent | BEHAVIORAL TECHNOLOGY, INC. |
| K000194 | DIGITAL INFLECTION RIGIDOMETER (DIR) | Apr 10, 2000 | Substantially Equivalent | UROAN XXI ELECTROMEDICINA |
| K991479 | VISER PENILE TUMESCENCE MONITOR | Jul 07, 1999 | Substantially Equivalent | LABORIE MEDICAL TECH CORP. |
| K980627 | NEVA SYSTEM | Apr 07, 1998 | Substantially Equivalent | UROMETRICS, INC. |
| K940128 | CAT-400UL PENILE PLETHYSMOGRAPH | Jan 10, 1995 | Substantially Equivalent | FARRALL INSTRUMENTS, INC. |
| K936115 | CAT-600 PENILE PLETHYSMOGRAPH | Jan 10, 1995 | Substantially Equivalent | FARRALL INSTRUMENTS, INC. |
| K941781 | RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM | Aug 25, 1994 | Substantially Equivalent | DACOMED CORP. |
| K925931 | RT2 RIGIDITY AND TUMESCENCE TEST | Dec 21, 1992 | Substantially Equivalent | COMPASS MEDICAL TECHNOLOGIES, INC. |
| K880903 | BARD (R) ESKA ERECTIOMETER | May 06, 1988 | Substantially Equivalent | C.R. BARD, INC. |
| K875333 | SURGITEK NPT MONITOR | Apr 13, 1988 | Substantially Equivalent | SURGITEK |
| K870983 | NOCTURNAL PENILE TUMESCENCE MONITOR | Jun 23, 1987 | Substantially Equivalent | TEXAS MEDICAL ELECTRONICS CO. |
| K851646 | VIBRECTOR | Aug 21, 1985 | Substantially Equivalent | MULTICEPT, APS. |
| K841879 | LFT - 212 | Jul 26, 1984 | Substantially Equivalent | MEDICAL MONITORING SYSTEMS, INC. |
| K841202 | DACOMED RIGISCAN SYSTEM | Jul 06, 1984 | Substantially Equivalent | DACOMED CORP. |
| K833454 | BIOREM 3000 & 4000 | Feb 21, 1984 | Substantially Equivalent | BIOREM |
| K832121 | DACOMED SNAP-GAUGE | Jul 18, 1983 | Substantially Equivalent | DACOMED CORP. |
| K831251 | TUMISENSOR 1524 | Jun 03, 1983 | Substantially Equivalent | LIFE-TECH INTL., INC. |
| K831252 | TUMISTORE RECORDER 1311 | May 18, 1983 | Substantially Equivalent | LIFE-TECH INTL., INC. |
| K830221 | BEDSIDE N.P.T. 9900 - PRINTER 9800 | Mar 17, 1983 | Substantially Equivalent | BROWNE MEDICAL, INC. |
| K830158 | OREXAS POTENTEST | Feb 07, 1983 | Substantially Equivalent | OREXAS MEDICAL CORP. |
| K822099 | BIOREM 2000 | Aug 27, 1982 | Substantially Equivalent | BIOREM |
| K820615 | DACOMED SNAP-GAUGE | Apr 21, 1982 | Substantially Equivalent | DACOMED CORP. |
| K810944 | PENILE ERECTION MONITOR | Apr 23, 1981 | Substantially Equivalent | MEDICAL MONITORING SYSTEMS, INC. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.