KPIClass II
Stimulator, Electrical, Non-Implantable, For Incontinence
21 CFR 876.5320 / Gastroenterology, Urology
KPI is the FDA product code for Stimulator, Electrical, Non-Implantable, For Incontinence, a class II device type, regulated under 21 CFR 876.5320. As of , FDA records hold 96 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- KPI
- Device name
- Stimulator, Electrical, Non-Implantable, For Incontinence
- Regulation
- 21 CFR 876.5320
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 97
- Ingested recalls
- 0
Clearances, product code KPI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1985 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1993 | 1 |
| 1995 | 4 |
| 1996 | 4 |
| 1997 | 11 |
| 1998 | 2 |
| 1999 | 3 |
| 2000 | 4 |
| 2001 | 3 |
| 2003 | 5 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 2 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 6 |
| 2016 | 3 |
| 2017 | 1 |
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 3 |
| 2023 | 3 |
| 2024 | 4 |
| 2025 | 4 |
| 2026 | 7 |
Applicants with the most clearances
Product code KPI| Applicant | Clearances |
|---|---|
| Hollister, Inc. | 10 |
| Incontrol Medical, LLC | 7 |
| Empi | 5 |
| Shenzhen Konmed Technology Co., Ltd | 4 |
| Tenscare Ltd. | 4 |
| The Prometheus Group | 4 |
| Utah Medical Products, Inc | 4 |
| BTL Industries, Inc | 3 |
| Athena Feminine Technologies, Inc. | 2 |
| Empi | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.