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
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 15 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 391 |
| 2019 | 0 | — |
| 2020 | 2 | 144 |
| 2021 | 1 | 163 |
| 2022 | 2 | 268 |
| 2023 | 1 | 506 |
| 2024 | 0 | — |
| 2025 | 2 | 163 |
| 2026 | 4 | 157 |
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 code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 5 | 5 |
| CAW | Generator, Oxygen, Portable | 3 | 3 |
| FLL | Continuous Measurement Thermometer | 3 | 3 |
| DQA | Oximeter | 2 | 2 |
| IOR | Wheelchair, Mechanical | 2 | 2 |
Review panels
- Anesthesiology (5)
- Cardiovascular (5)
- General Hospital (3)
- Physical Medicine (2)
Most recent Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261571 | Manual Wheelchair (H008, PCK7) | IOR | 2026-08-06 | 86 |
| K252779 | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | DXN | 2026-03-05 | 184 |
| K253228 | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | DXN | 2026-02-23 | 147 |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | DQA | 2026-02-17 | 167 |
| K242736 | Portable Oxygen Concentrator (Spirit-3) | CAW | 2025-06-05 | 267 |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) | FLL | 2025-05-22 | 59 |
| K213825 | Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A | CAW | 2023-04-28 | 506 |
| K221372 | YUWELL Electronic Blood Pressure Monitor | DXN | 2022-10-17 | 158 |
| K212385 | YUWELL Finger Pulse Oximeter | DQA | 2022-08-16 | 379 |
| K203583 | YUWELL infrared ear thermometer: YHT101, YHT200 | FLL | 2021-05-20 | 163 |
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.
- Jiangsu Caina Medical Co.,Ltd (15 510(k)s)
- Jiangsu Cureguard Glove Co., Ltd. (11 510(k)s)
- Jiangsu Vedkang Medical Science and Technology Co., Ltd. (7 510(k)s)
- Jiangsu Jumao X-Care Medical Equipment Co., Ltd. (5 510(k)s)
- Jiangsu Kangbao Medical Equipment Co., Ltd. (5 510(k)s)
- Jiangsu Micsafe Medical Technology Co., Ltd. (5 510(k)s)
- Jiangsu Intco Medical Equipment & Supply Co., Ltd. (4 510(k)s)
- Jiangsu Sunshine Plastic Products, Co., Ltd. (4 510(k)s)
- Jiangsu Intco Medical Products Co., Ltd. (3 510(k)s)
- Jiangsu Jaysun Glove Co., Ltd. (3 510(k)s)
- Jiangsu Shenli Medical Production Co., Ltd. (3 510(k)s)
- Jiangsu Alfa Glove Co., Ltd. (2 510(k)s)
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
- See all 15 Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.'s most frequent
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.