Shenzhen Med-Link Electronics Tech Co., Ltd.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Shenzhen Med-Link Electronics Tech Co., Ltd.” (first 2009, latest 2026), across 7 product codes in 5 review panels. Median 510(k) review time under this name: 264 days. Since 2017 the median was 264 days, against 177 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 | 16 |
| 2013 | 1 | 458 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 277 |
| 2017 | 0 | — |
| 2018 | 1 | 225 |
| 2019 | 2 | 362 |
| 2020 | 1 | 267 |
| 2021 | 2 | 190 |
| 2022 | 2 | 198 |
| 2023 | 1 | 337 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 268 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shenzhen Med-Link Electronics Tech Co., Ltd. took a median 264 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 177 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQA | Oximeter | 4 | 4 |
| FLL | Continuous Measurement Thermometer | 3 | 3 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 2 | 2 |
| DXQ | Blood Pressure Cuff | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 1 | 1 |
Review panels
- Cardiovascular (5)
- Anesthesiology (4)
- General Hospital (3)
- Gastroenterology and Urology (1)
- Neurology (1)
Most recent Shenzhen Med-Link Electronics Tech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) | FLL | 2026-01-08 | 268 |
| K220448 | Disposable Non-invasive EEG Sensor | GXY | 2023-01-19 | 337 |
| K220447 | Med-link Disposable ECG Cable and Leadwires | DSA | 2022-06-28 | 132 |
| K212752 | Med-link Pulse Oximeter | DQA | 2022-05-20 | 263 |
| K210441 | Incontinence Probe | KPI | 2021-09-17 | 217 |
| K202743 | Med-Link Temp-pulse Oximeter | DQA | 2021-03-01 | 164 |
| K193338 | Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes | FLL | 2020-08-25 | 267 |
| K181154 | Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor | DXN | 2019-08-02 | 458 |
| K182667 | Med-link Temperature Probes | FLL | 2019-06-18 | 266 |
| K173869 | Med-link Reusable Blood Pressure Cuff | DXQ | 2018-08-02 | 225 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen Med-Link Electronics Tech 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Shenzhen Med-Link Electronics Tech Co., Ltd. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
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 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)
- Shenzhen Kentro Medical Electronics Co., Ltd. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shenzhen Med-Link Electronics Tech Co., Ltd.?
FDA lists 14 510(k) clearances under the applicant name “Shenzhen Med-Link Electronics Tech Co., Ltd.” (first 2009, latest 2026), across 7 product codes in 5 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 Med-Link Electronics Tech Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shenzhen Med-Link Electronics Tech Co., Ltd. is 264 days. Since 2017: 264 days, versus 177 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shenzhen Med-Link Electronics Tech Co., Ltd.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 4); FLL (Continuous Measurement Thermometer, 3); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 2).
Next steps
- See all 14 Shenzhen Med-Link Electronics Tech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Shenzhen Med-Link Electronics Tech 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.