Dantec Electronics, Inc.: FDA clearances and approvals
Dantec Electronics, Inc. has 12 FDA 510(k) clearances (first 1985, latest 1990), across 6 product codes in 2 review panels. Median 510(k) review time: 154 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | 4 | 4 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 3 | 3 |
| FFO | Retractor, Self-Retaining | 2 | 2 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| GXZ | Electrode, Needle | 1 | 1 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 1 | 1 |
Review panels
Most recent Dantec Electronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K895460 | CONCENTRIC ELECTRODE TYPE #13R01, 13R02 | IKT | 1990-06-18 | 285 |
| K894911 | SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 | GXZ | 1990-05-14 | 286 |
| K884915 | DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER | FAP | 1989-10-04 | 310 |
| K881915 | DANTEC MAGNETIC STIMULATOR | GWF | 1988-10-17 | 161 |
| K874759 | 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE | FAP | 1988-04-14 | 148 |
| K874758 | DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE | FAP | 1988-04-14 | 148 |
| K874735 | DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE | GXY | 1988-01-22 | 65 |
| K870567 | EVOPORT 300 | GWF | 1987-10-06 | 238 |
| K872106 | DANTEC COUNTERPOINT | GWF | 1987-09-10 | 101 |
| K860368 | URDYN 5000 (UROFLOWMETER) | FFO | 1986-04-23 | 79 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dantec Electronics, 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.
Frequently asked questions
How many FDA 510(k) clearances does Dantec Electronics, Inc. have?
Dantec Electronics, Inc. has 12 FDA 510(k) clearances (first 1985, latest 1990), across 6 product codes in 2 review panels.
How long does FDA take to clear Dantec Electronics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Dantec Electronics, Inc.'s cleared 510(k)s is 154 days.
What devices does Dantec Electronics, Inc. make?
Its most frequent FDA product codes are GWF (Stimulator, Electrical, Evoked Response, 4); FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, 3); FFO (Retractor, Self-Retaining, 2).
Has Dantec Electronics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dantec Electronics, Inc. Related entities may recall under other names.
Next steps
- See all 12 Dantec Electronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWF, Dantec Electronics, 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.