Atlas FDA

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-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2026-08-06860
K252779YUWELL® Electronic Blood Pressure Monitor (YE630CR)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2026-03-051840
K253228YUWELL® Electronic Blood Pressure Monitor (YE650AR)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2026-02-231470
K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2026-02-171670
K242736Portable Oxygen Concentrator (Spirit-3)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2025-06-052670
K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2025-05-22590
K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2023-04-285060
K221372YUWELL Electronic Blood Pressure MonitorJiangsu Yuyue Medical Equipment & Supply Co., Ltd.2022-10-171580
K212385YUWELL Finger Pulse OximeterJiangsu Yuyue Medical Equipment & Supply Co., Ltd.2022-08-163790
K203583YUWELL infrared ear thermometer: YHT101, YHT200Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2021-05-201630
K201864YUWELL Infrared ThermometerJiangsu Yuyue Medical Equipment & Supply Co., Ltd.2020-12-071540
K200939Electronic Blood Pressure MonitorJiangsu Yuyue Medical Equipment & Supply Co., Ltd.2020-08-201340
K170605Upper Arm Type Electronic Blood Pressure Monitor Series, EleJiangsu Yuyue Medical Equipment & Supply Co., Ltd.2018-03-273910
K120526YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIRJiangsu Yuyue Medical Equipment & Supply Co., Ltd.2012-03-08150
K083559YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5BJiangsu Yuyue Medical Equipment & Supply Co., Ltd.2009-09-042760

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