FDA product code KPI: Stimulator, Electrical, Non-Implantable, For Incontinence
KPI is the FDA product code for stimulator, electrical, non-implantable, for incontinence. It is a Class II device, regulated under 21 CFR 876.5320 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 94 510(k) submissions under KPI, 18 in the last five years, from 51 different applicants. The average 510(k) review took 175 days (median 152); 223 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Electrical, Non-Implantable, For Incontinence |
| Device class | Class II |
| Regulation | 21 CFR 876.5320 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KPI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 417 |
| 2018 | 3 | 295 |
| 2019 | 2 | 200 |
| 2020 | 1 | 90 |
| 2021 | 3 | 185 |
| 2022 | 3 | 169 |
| 2023 | 3 | 193 |
| 2024 | 4 | 180 |
| 2025 | 4 | 237 |
| 2026 | 4 | 253 |
Compare with all 510(k) review times · Search every KPI clearance
Top KPI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hollister, Inc. | 10 | 2005-04-12 |
| Empi | 8 | 1998-11-03 |
| Incontrol Medical, LLC | 7 | 2019-03-15 |
| Tenscare, Ltd. | 4 | 2023-10-20 |
| The Prometheus Group | 4 | 2003-05-23 |
46 more applicants have KPI clearances. See the full list in Caduvo.
Most recent KPI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252552 | Shenzhen Changkun Technology Co., Ltd. | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) | 2026-05-06 | 266 |
| K252831 | Dolanvy (Suzhou) Medical Technology Co., Ltd. | Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) | 2026-04-28 | 235 |
| K252334 | Pontemedag | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) | 2026-04-17 | 263 |
| K251760 | Well-Life Healthcare , Ltd. | Well-Life Incontinence Stimulation System (WL-2405i(P)) | 2026-02-12 | 248 |
| K251026 | Trinity Medical Solutions | Regenesis EMS Chair | 2025-08-29 | 149 |
Recalls for KPI devices
openFDA lists no recalls for product code KPI.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month
- C1767 — Generator, neurostimulator (implantable), non-rechargeable
Frequently asked questions
What is FDA product code KPI?
KPI is the FDA product code for stimulator, electrical, non-implantable, for incontinence. It is a Class II device, regulated under 21 CFR 876.5320 and reviewed by the Gastroenterology and Urology panel.
What device class is KPI?
Class II, regulation 21 CFR 876.5320. Typical premarket route: 510(k).
How long does a 510(k) take for product code KPI?
Across 94 cleared submissions the average was 175 days from receipt to decision (median 152).
Which companies have the most KPI clearances?
Hollister, Inc. (10); Empi (8); Incontrol Medical, LLC (7); Tenscare, Ltd. (4); The Prometheus Group (4).
Next steps
- Run an FDA pathway report with predicate devices for product code KPI
- Run a recall and safety report across every KPI manufacturer
- Watch product code KPI 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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