Nemectron Medical, Inc.: FDA clearances and approvals
Nemectron Medical, Inc. has 13 FDA 510(k) clearances (first 1980, latest 1993), across 8 product codes in 3 review panels. Median 510(k) review time: 104 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 2 | 2 |
| KCX | Epilator, High Frequency, Tweezer-Type | 2 | 2 |
| HCC | Device, Biofeedback | 1 | 1 |
| IOA | Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| IRT | Pad, Heating, Powered | 1 | 1 |
| LIH | Interferential Current Therapy | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Nemectron Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923396 | THERMODYN | IRT | 1993-05-26 | 320 |
| K895000 | NEMECTRON MICROWAVE | IOA | 1990-07-27 | 353 |
| K862376 | NEMECTROSON MODEL 2 | IMJ | 1986-07-23 | 29 |
| K854720 | NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM. | IPF | 1986-03-10 | 108 |
| K854721 | NEMECTRODYN MODEL 2 & ENDOVAC 2 | LIH | 1986-03-06 | 104 |
| K844416 | THERMOPULS E | IMJ | 1985-03-12 | 118 |
| K843735 | SOFTEPIL | KCX | 1984-10-25 | 31 |
| K843734 | NEMDI | KCX | 1984-10-25 | 31 |
| K823511 | EMG BIOFEEDBACK DEVICE | HCC | 1983-03-31 | 122 |
| K820334 | NEMECTRODYN MODELS 8,7,5 (VOLS. I-IV | — | 1982-03-15 | 38 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nemectron Medical, 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 Nemectron Medical, Inc. have?
Nemectron Medical, Inc. has 13 FDA 510(k) clearances (first 1980, latest 1993), across 8 product codes in 3 review panels.
How long does FDA take to clear Nemectron Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Nemectron Medical, Inc.'s cleared 510(k)s is 104 days.
What devices does Nemectron Medical, Inc. make?
Its most frequent FDA product codes are IPF (Stimulator, Muscle, Powered, 3); IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat, 2); KCX (Epilator, High Frequency, Tweezer-Type, 2).
Has Nemectron Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Nemectron Medical, Inc. Related entities may recall under other names.
Next steps
- See all 13 Nemectron Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Nemectron Medical, 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.