Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Kentro Medical Electronics Co., Ltd. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
230 daysmedian FDA review time
428 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242332 | Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-23 | Shenzhen Kentro Medical Electronics Co., Ltd. | 2024-11-05 | 90 | 0 |
| K232517 | Transcutaneous Electrical Nerve Stimulator For Pain Relief ( | Shenzhen Kentro Medical Electronics Co., Ltd. | 2023-12-08 | 112 | 0 |
| K222870 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, | Shenzhen Kentro Medical Electronics Co., Ltd. | 2023-05-10 | 230 | 0 |
| K220998 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 | Shenzhen Kentro Medical Electronics Co., Ltd. | 2022-08-24 | 142 | 0 |
| K200177 | Low-frequency Multi-function physiotherapy instrument | Shenzhen Kentro Medical Electronics Co., Ltd. | 2021-03-25 | 426 | 0 |
| K200237 | Transcutaneous Electronic Nerve Stimulator | Shenzhen Kentro Medical Electronics Co., Ltd. | 2020-10-19 | 269 | 0 |
| K191982 | Low-Frequency Multi-function Physiotherapy Instrument (Model | Shenzhen Kentro Medical Electronics Co., Ltd. | 2020-09-25 | 428 | 0 |
| K183288 | Transcutaneous Electrical Nerve Stimulator | Shenzhen Kentro Medical Electronics Co., Ltd. | 2019-07-30 | 246 | 0 |
| K181728 | Muscle Trainer | Shenzhen Kentro Medical Electronics Co., Ltd. | 2018-10-17 | 110 | 0 |
| K170205 | Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, K | Shenzhen Kentro Medical Electronics Co., Ltd. | 2017-05-11 | 108 | 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