Hivox Biotek, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Hivox Biotek, Inc.” (first 2002, latest 2026), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 144 days. Since 2017 the median was 92 days, against 163 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 |
|---|---|---|
| 2012 | 1 | 214 |
| 2013 | 0 | — |
| 2014 | 2 | 257 |
| 2015 | 2 | 196 |
| 2016 | 0 | — |
| 2017 | 1 | 163 |
| 2018 | 0 | — |
| 2019 | 2 | 54 |
| 2020 | 0 | — |
| 2021 | 2 | 128 |
| 2022 | 1 | 29 |
| 2023 | 2 | 116 |
| 2024 | 1 | 90 |
| 2025 | 0 | — |
| 2026 | 1 | 126 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hivox Biotek, Inc. took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 163 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 11 | 11 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 3 | 3 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
Review panels
- Neurology (14)
- Physical Medicine (3)
- General Hospital (1)
Most recent Hivox Biotek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260425 | TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) | NUH | 2026-06-16 | 126 |
| K242815 | POCKET TENS (EP-300) | NUH | 2024-12-17 | 90 |
| K232675 | Heating Tens, FT-615 | NUH | 2023-10-05 | 34 |
| K223308 | HEATING TENS/EMS, FT-810R | NUH | 2023-05-13 | 197 |
| K221384 | Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 | NUH | 2022-06-11 | 29 |
| K211403 | HIVOX OTC Electrical Stimulator, FT610-B | NUH | 2021-10-15 | 162 |
| K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 | NUH | 2021-03-10 | 93 |
| K192264 | HIVOX Spopad EMS SP-911, SP-921 | NGX | 2019-11-08 | 79 |
| K190347 | HIVOX OTC Electrical Stimulator | NUH | 2019-03-15 | 29 |
| K171803 | HIVOX OTC Electrical Stimulator | NUH | 2017-11-29 | 163 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hivox Biotek, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hivox Biotek, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Hivox Biotek, Inc.” (first 2002, latest 2026), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hivox Biotek, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hivox Biotek, Inc. is 144 days. Since 2017: 92 days, versus 163 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hivox Biotek, Inc.?
The most frequent FDA product codes under this applicant name are NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 11); NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 3); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 2).
Next steps
- See all 18 Hivox Biotek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NUH, Hivox Biotek, Inc.'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.