Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.: FDA filings under this applicant name

FDA lists 15 510(k) clearances under the applicant name “Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.” (first 2009, latest 2026), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 163 days. Since 2017 the median was 163 days, against 189 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

YearClearancesMedian review days
2012115
20130—
20140—
20150—
20160—
20170—
20181391
20190—
20202144
20211163
20222268
20231506
20240—
20252163
20264157

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. took a median 163 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 189 days.

Top product codes

Product codeDeviceSubmissions510(k) clearances
DXNSystem, Measurement, Blood-Pressure, Non-Invasive55
CAWGenerator, Oxygen, Portable33
FLLContinuous Measurement Thermometer33
DQAOximeter22
IORWheelchair, Mechanical22

Review panels

Most recent Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. 510(k) clearances

510(k)DeviceProduct codeDecision dateReview days
K261571Manual Wheelchair (H008, PCK7)IOR2026-08-0686
K252779YUWELL® Electronic Blood Pressure Monitor (YE630CR)DXN2026-03-05184
K253228YUWELL® Electronic Blood Pressure Monitor (YE650AR)DXN2026-02-23147
K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)DQA2026-02-17167
K242736Portable Oxygen Concentrator (Spirit-3)CAW2025-06-05267
K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)FLL2025-05-2259
K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5ACAW2023-04-28506
K221372YUWELL Electronic Blood Pressure MonitorDXN2022-10-17158
K212385YUWELL Finger Pulse OximeterDQA2022-08-16379
K203583YUWELL infrared ear thermometer: YHT101, YHT200FLL2021-05-20163

5 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Jiangsu Yuyue Medical Equipment & Supply Co., Ltd..

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

Frequently asked questions

How many FDA 510(k) clearances are listed under Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.?

FDA lists 15 510(k) clearances under the applicant name “Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.” (first 2009, latest 2026), across 5 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. is 163 days. Since 2017: 163 days, versus 189 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.?

The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 5); CAW (Generator, Oxygen, Portable, 3); FLL (Continuous Measurement Thermometer, 3).

Next steps

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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