Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Konmed Technology Co., Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
181 daysmedian FDA review time
422 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260178 | Pelvic Muscle Trainer (KM510, KM516B) | Shenzhen Konmed Technology Co., Ltd. | 2026-06-18 | 148 | 0 |
| K233576 | Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM | Shenzhen Konmed Technology Co., Ltd. | 2024-02-23 | 108 | 0 |
| K220161 | Biofeedback Nerve and Muscle Stimulator | Shenzhen Konmed Technology Co., Ltd. | 2022-07-20 | 181 | 0 |
| K202648 | Biofeedback Nerve and Muscle Stimulator | Shenzhen Konmed Technology Co., Ltd. | 2020-12-08 | 88 | 0 |
| K163288 | Pelvifine Pelvic Muscle Trainer | Shenzhen Konmed Technology Co., Ltd. | 2018-01-18 | 422 | 0 |
| K171722 | Electrodes with snap / Electrodes with pigtail | Shenzhen Konmed Technology Co., Ltd. | 2018-01-10 | 212 | 0 |
| K171721 | Electrodes with silver conductive | Shenzhen Konmed Technology Co., Ltd. | 2018-01-05 | 207 | 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