Dyansys, Inc.: FDA clearances and approvals
Dyansys, Inc. has 15 FDA 510(k) clearances (first 2007, latest 2022), across 5 product codes in 3 review panels. Median 510(k) review time: 90 days. Since 2017 its median was 103 days, against 192 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 5 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 374 |
| 2016 | 0 | — |
| 2017 | 1 | 29 |
| 2018 | 1 | 133 |
| 2019 | 0 | — |
| 2020 | 1 | 90 |
| 2021 | 2 | 118 |
| 2022 | 4 | 105 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Dyansys, Inc.'s cleared 510(k)s took a median 103 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 192 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPS | Electrocardiograph | 5 | 5 |
| NHI | Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | 4 | 4 |
| PZR | Percutaneous Nerve Stimulator For Opioid Withdrawal | 3 | 3 |
| BWK | Stimulator, Electro-Acupuncture | 2 | 2 |
| QHH | Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs) | 1 | 1 |
Review panels
Most recent Dyansys, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221425 | Primary Relief | NHI | 2022-09-13 | 120 |
| K221231 | Drug Relief v1 | PZR | 2022-06-06 | 38 |
| K220397 | ANSiStim-PP | NHI | 2022-05-12 | 90 |
| K213188 | Primary Relief | NHI | 2022-01-31 | 124 |
| K212859 | First Relief | NHI | 2021-12-20 | 103 |
| K211971 | Drug Relief v1 | PZR | 2021-11-05 | 134 |
| K202940 | First Relief v1 | QHH | 2020-12-29 | 90 |
| K173861 | Drug Relief | PZR | 2018-05-02 | 133 |
| K170391 | ANSiStim-PP | BWK | 2017-03-09 | 29 |
| K141168 | ANSISTIM | BWK | 2015-05-15 | 374 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dyansys, Inc..
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.
Device clinical trials
Dyansys, Inc. is the industry lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05742711: Efficacy of PENS of the Auricle as an Opioid Sparing Postoperative Analgesic Technique in Cancer Endometrium and Cancer Cervix Patients (Completed, started 2023-05-16)
- NCT05199350: Distinguishing Participant Groups Using Autonomic Dysfunction (Completed, started 2021-11-17)
- NCT04106739: A Study of New Treatment for Excessive Alcohol Users by Electric Stimulation of Nerves Around Ear (Completed, started 2019-10-20)
- NCT04094974: Heartrate Variability and Intraoperative Brain Conditions in Supratentorial Tumors (Completed, started 2019-10-12)
- NCT03750357: Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Post Operative Pain Solution(POPS) - Cardiac Surgery (Completed, started 2018-10-11)
Frequently asked questions
How many FDA 510(k) clearances does Dyansys, Inc. have?
Dyansys, Inc. has 15 FDA 510(k) clearances (first 2007, latest 2022), across 5 product codes in 3 review panels.
How long does FDA take to clear Dyansys, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Dyansys, Inc.'s cleared 510(k)s is 90 days. Since 2017: 103 days, versus 192 days for all cleared 510(k)s in the same product codes.
What devices does Dyansys, Inc. make?
Its most frequent FDA product codes are DPS (Electrocardiograph, 5); NHI (Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief, 4); PZR (Percutaneous Nerve Stimulator For Opioid Withdrawal, 3).
Has Dyansys, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dyansys, Inc. Related entities may recall under other names.
Next steps
- See all 15 Dyansys, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Dyansys, Inc.'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.