Incontrol Medical, LLC: FDA clearances and approvals
Incontrol Medical, LLC has 7 FDA 510(k) clearances (first 2012, latest 2019), across 1 product code in 1 review panel. Median 510(k) review time: 72 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 397 |
| 2013 | 0 | — |
| 2014 | 3 | 57 |
| 2015 | 2 | 60 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 231 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Incontrol Medical, LLC's cleared 510(k)s took a median 231 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 208 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 7 | 7 |
Review panels
Most recent Incontrol Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182022 | ApexMV | KPI | 2019-03-15 | 231 |
| K150183 | ApexM | KPI | 2015-04-09 | 72 |
| K150180 | InTone | KPI | 2015-03-16 | 48 |
| K141158 | APEX | KPI | 2014-11-26 | 205 |
| K134020 | INTONEMV | KPI | 2014-02-25 | 57 |
| K133826 | INTONEMV | KPI | 2014-01-06 | 20 |
| K110179 | INCONTROL | KPI | 2012-02-22 | 397 |
Recalls
openFDA lists no recalls under a recalling firm named Incontrol Medical, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Incontrol Medical, LLC's product codes (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Frequently asked questions
How many FDA 510(k) clearances does Incontrol Medical, LLC have?
Incontrol Medical, LLC has 7 FDA 510(k) clearances (first 2012, latest 2019), across 1 product code in 1 review panel.
How long does FDA take to clear Incontrol Medical, LLC's 510(k)s?
The median time from FDA receipt to decision across Incontrol Medical, LLC's cleared 510(k)s is 72 days.
What devices does Incontrol Medical, LLC make?
Its most frequent FDA product codes are KPI (Stimulator, Electrical, Non-Implantable, For Incontinence, 7).
Has Incontrol Medical, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Incontrol Medical, LLC. Related entities may recall under other names.
Next steps
- See all 7 Incontrol Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code KPI, Incontrol Medical, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.