Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Wuxi Jiajian Medical Instrument Co., Ltd. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
263 daysmedian FDA review time
333 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K244030 | Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2025-03-28 | 88 | 0 |
| K231425 | Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2024-03-27 | 315 | 0 |
| K222879 | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS | Wuxi Jiajian Medical Instrument Co., Ltd. | 2023-01-24 | 124 | 0 |
| K202861 | Needle Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021-08-27 | 333 | 0 |
| K202893 | Transcutaneous Electrical Nerve Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021-06-18 | 263 | 0 |
| K192568 | Jiajian Self-Adhesive Electrode | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021-02-03 | 504 | 0 |
| K123958 | JIAJIAN POINTOSELECT DIGITAL | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013-10-28 | 311 | 0 |
| K130768 | JIAJIAN CMN STIMULATOR | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013-08-16 | 149 | 0 |
| K122812 | JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013-04-11 | 210 | 0 |
| K112288 | JIAJIAN TENS | Wuxi Jiajian Medical Instrument Co., Ltd. | 2012-05-02 | 267 | 0 |
| K090199 | JIAJIAN ACUPUNCTURE NEEDLE | Wuxi Jiajian Medical Instrument Co., Ltd. | 2009-08-11 | 196 | 0 |
| K090198 | JIAJIAN SELF-ADHESIVE ELECTRODE | Wuxi Jiajian Medical Instrument Co., Ltd. | 2009-06-23 | 147 | 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