Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
163 daysmedian FDA review time
391 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261571 | Manual Wheelchair (H008, PCK7) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-08-06 | 86 | 0 |
| K252779 | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-03-05 | 184 | 0 |
| K253228 | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-02-23 | 147 | 0 |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-02-17 | 167 | 0 |
| K242736 | Portable Oxygen Concentrator (Spirit-3) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025-06-05 | 267 | 0 |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025-05-22 | 59 | 0 |
| K213825 | Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8 | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2023-04-28 | 506 | 0 |
| K221372 | YUWELL Electronic Blood Pressure Monitor | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2022-10-17 | 158 | 0 |
| K212385 | YUWELL Finger Pulse Oximeter | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2022-08-16 | 379 | 0 |
| K203583 | YUWELL infrared ear thermometer: YHT101, YHT200 | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2021-05-20 | 163 | 0 |
| K201864 | YUWELL Infrared Thermometer | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2020-12-07 | 154 | 0 |
| K200939 | Electronic Blood Pressure Monitor | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2020-08-20 | 134 | 0 |
| K170605 | Upper Arm Type Electronic Blood Pressure Monitor Series, Ele | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2018-03-27 | 391 | 0 |
| K120526 | YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2012-03-08 | 15 | 0 |
| K083559 | YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2009-09-04 | 276 | 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