Coapt, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Coapt, LLC” (first 2017, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time under this name: 30 days. Since 2017 the median was 30 days, against 128 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 179 |
| 2018 | 0 | — |
| 2019 | 2 | 36 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 28 |
| 2023 | 1 | 28 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Coapt, LLC took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXY | Electrode, Cutaneous | 5 | 5 |
Review panels
- Neurology (5)
Most recent Coapt, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223738 | Alpha Control Liner System (ACLS) | GXY | 2023-01-11 | 28 |
| K223605 | ControlSeal Electrode (ELSB) | GXY | 2022-12-30 | 28 |
| K191083 | COMPLETE CONTROL System Gen2 | GXY | 2019-05-24 | 30 |
| K190416 | Dome Electrode | GXY | 2019-04-04 | 42 |
| K162891 | Complete Control System | GXY | 2017-04-14 | 179 |
Recalls
2 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2023-10-02.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Coapt, LLC is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04272489: Pattern Recognition Prosthetic Control (Completed, started 2020-12-17)
- NCT04272593: Pattern Recognition Prosthetic Control (Completed, started 2020-11-16)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Coapt Systems, Inc. (17 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Coapt, LLC?
FDA lists 5 510(k) clearances under the applicant name “Coapt, LLC” (first 2017, latest 2023), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Coapt, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Coapt, LLC is 30 days. Since 2017: 30 days, versus 128 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Coapt, LLC?
The most frequent FDA product codes under this applicant name are GXY (Electrode, Cutaneous, 5).
Next steps
- See all 5 Coapt, LLC clearances with predicates and recalls
- Run predicate analysis for product code GXY, Coapt, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.