Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Med-Link Electronics Tech Co., Ltd. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
266 daysmedian FDA review time
458 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS- | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2026-01-08 | 268 | 0 |
| K220448 | Disposable Non-invasive EEG Sensor | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2023-01-19 | 337 | 0 |
| K220447 | Med-link Disposable ECG Cable and Leadwires | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2022-06-28 | 132 | 0 |
| K212752 | Med-link Pulse Oximeter | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2022-05-20 | 263 | 0 |
| K210441 | Incontinence Probe | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2021-09-17 | 217 | 0 |
| K202743 | Med-Link Temp-pulse Oximeter | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2021-03-01 | 164 | 0 |
| K193338 | Med-link Reusable Temperature Probes, Med-link Disposable Te | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2020-08-25 | 267 | 0 |
| K181154 | Med-link Wrist Digital Blood Pressure Monitor, Med-link Uppe | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2019-08-02 | 458 | 0 |
| K182667 | Med-link Temperature Probes | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2019-06-18 | 266 | 0 |
| K173869 | Med-link Reusable Blood Pressure Cuff | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2018-08-02 | 225 | 0 |
| K160530 | Med-link Reusable Blood Pressure Cuff, Med-link Disposable B | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2016-11-28 | 277 | 0 |
| K113727 | SHENZHEN MED-LINK PULSE OXIMETER PROBE | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2013-03-21 | 458 | 0 |
| K120010 | CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2012-01-19 | 16 | 0 |
| K083010 | SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2009-06-10 | 244 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda