Shenzhen Kentro Medical Electronics Co., Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Shenzhen Kentro Medical Electronics Co., Ltd.” (first 2017, latest 2024), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 186 days. Since 2017 the median was 186 days, against 140 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 | 108 |
| 2018 | 1 | 110 |
| 2019 | 1 | 246 |
| 2020 | 2 | 348 |
| 2021 | 1 | 426 |
| 2022 | 1 | 142 |
| 2023 | 2 | 171 |
| 2024 | 1 | 90 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shenzhen Kentro Medical Electronics Co., Ltd. took a median 186 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 9 | 9 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 1 | 1 |
Review panels
- Neurology (9)
- Physical Medicine (1)
Most recent Shenzhen Kentro Medical Electronics Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242332 | Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494) | NUH | 2024-11-05 | 90 |
| K232517 | Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412) | NUH | 2023-12-08 | 112 |
| K222870 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 | NUH | 2023-05-10 | 230 |
| K220998 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 | NUH | 2022-08-24 | 142 |
| K200177 | Low-frequency Multi-function physiotherapy instrument | NUH | 2021-03-25 | 426 |
| K200237 | Transcutaneous Electronic Nerve Stimulator | NUH | 2020-10-19 | 269 |
| K191982 | Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) | NUH | 2020-09-25 | 428 |
| K183288 | Transcutaneous Electrical Nerve Stimulator | NUH | 2019-07-30 | 246 |
| K181728 | Muscle Trainer | NGX | 2018-10-17 | 110 |
| K170205 | Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 | NUH | 2017-05-11 | 108 |
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen Kentro Medical Electronics Co., Ltd..
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.
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.
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (160 510(k)s)
- Shenzhen Dongdixin Technology Co., Ltd. (26 510(k)s)
- Shenzhen Kaiyan Medical Equipment Co., Ltd. (24 510(k)s)
- Shenzhen TPH Technology Co., Ltd. (24 510(k)s)
- Shenzhen Ulike Smart Electronics Co., Ltd. (23 510(k)s)
- Shenzhen AOJ Medical Technology Co., Ltd. (17 510(k)s)
- Shenzhen Beacon Display Technology Co., Ltd. (17 510(k)s)
- Shenzhen Med-Link Electronics Tech Co., Ltd. (14 510(k)s)
- Shenzhen RF Tech Co., Ltd. (12 510(k)s)
- Shenzhen Root Innovation Technology Co., Ltd. (12 510(k)s)
- Shenzhen Creative Industry Co., Ltd. (11 510(k)s)
- Shenzhen Jumper Medical Equipment Co., Ltd. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shenzhen Kentro Medical Electronics Co., Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Shenzhen Kentro Medical Electronics Co., Ltd.” (first 2017, latest 2024), across 2 product codes in 2 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 Shenzhen Kentro Medical Electronics Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shenzhen Kentro Medical Electronics Co., Ltd. is 186 days. Since 2017: 186 days, versus 140 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shenzhen Kentro Medical Electronics Co., Ltd.?
The most frequent FDA product codes under this applicant name are NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 9); NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 1).
Next steps
- See all 10 Shenzhen Kentro Medical Electronics Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NUH, Shenzhen Kentro Medical Electronics Co., Ltd.'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.