FDA product code LIL: Monitor, Penile Tumescence
LIL is the FDA product code for monitor, penile tumescence. It is a Unclassified device, reviewed by the Gastroenterology and Urology panel. FDA has cleared 26 510(k) submissions under LIL, from 19 different applicants. The average 510(k) review took 111 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Penile Tumescence |
| Device class | Unclassified |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every LIL clearance
Top LIL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dacomed Corp. | 4 | 1994-08-25 |
| Farrall Instruments, Inc. | 2 | 1995-01-10 |
| Medical Monitoring Systems, Inc. | 2 | 1984-07-26 |
| Biorem | 2 | 1984-02-21 |
| Life-Tech Intl., Inc. | 2 | 1983-06-03 |
14 more applicants have LIL clearances. See the full list in Caduvo.
Most recent LIL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K061676 | Uroan 21 | RIGIDOMETER, MODEL DIR-4U | 2006-12-27 | 196 |
| K062042 | Plethora Solutions | PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) | 2006-09-06 | 49 |
| K052929 | Limestone Technologies, Inc. | PREFTEST PROFESSIONAL SUITE | 2006-04-26 | 189 |
| K033126 | Behavioral Technology, Inc. | MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM | 2003-10-29 | 29 |
| K000194 | Uroan Xxi Electromedicina | DIGITAL INFLECTION RIGIDOMETER (DIR) | 2000-04-10 | 80 |
Recalls for LIL devices
openFDA lists no recalls for product code LIL.
Frequently asked questions
What is FDA product code LIL?
LIL is the FDA product code for monitor, penile tumescence. It is a Unclassified device, reviewed by the Gastroenterology and Urology panel.
What device class is LIL?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LIL?
Across 26 cleared submissions the average was 111 days from receipt to decision (median 68).
Which companies have the most LIL clearances?
Dacomed Corp. (4); Farrall Instruments, Inc. (2); Medical Monitoring Systems, Inc. (2); Biorem (2); Life-Tech Intl., Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code LIL
- Run a recall and safety report across every LIL manufacturer
- Watch product code LIL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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