Suzhou Master Machinery Manufacturing Co.,Ltd: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Suzhou Master Machinery Manufacturing Co.,Ltd” (first 2023, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. Since 2017 the median was 88 days, against 126 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 |
|---|---|---|
| 2023 | 1 | 123 |
| 2024 | 1 | 56 |
| 2025 | 3 | 87 |
| 2026 | 1 | 90 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Suzhou Master Machinery Manufacturing Co.,Ltd took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | 3 | 3 |
| ITI | Wheelchair, Powered | 2 | 2 |
| IOR | Wheelchair, Mechanical | 1 | 1 |
Review panels
Most recent Suzhou Master Machinery Manufacturing Co.,Ltd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253870 | Electric Wheelchair (MP148) | ITI | 2026-03-04 | 90 |
| K252687 | Manual Wheelchair (HM305-Air1, HM305-Air2) | IOR | 2025-11-21 | 87 |
| K251638 | Mobility Scooter (MS160C) | INI | 2025-07-22 | 54 |
| K242982 | Mobility Scooter (MS160A) | INI | 2025-01-31 | 127 |
| K241463 | Electric Wheelchair (MP201C); Electric Wheelchair (MP201L) | ITI | 2024-07-18 | 56 |
| K222711 | HS186B Scooter | INI | 2023-01-09 | 123 |
Recalls
openFDA lists no recalls under a recalling firm named Suzhou Master Machinery Manufacturing 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.
- Suzhou Endophix Co., Ltd. (4 510(k)s)
- Suzhou Leapmed Healthcare Corporation (4 510(k)s)
- Suzhou Minhua Medical Apparatus Supplies Co., Ltd. (4 510(k)s)
- Suzhou Zenith Vascular SciTech Limited (4 510(k)s)
- Suzhou Colour-Way New Material Co., Ltd. (3 510(k)s)
- Suzhou Hengrui Disheng Medical Co., Ltd. (3 510(k)s)
- Suzhou Kangli Orthopaedics Instrument Co., Ltd. (3 510(k)s)
- Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. (3 510(k)s)
- Suzhou 66 Vision Tech Co., Ltd. (2 510(k)s)
- Suzhou AcuVu Medical Technology Co., Ltd. (2 510(k)s)
- Suzhou Borage Medical Technology Co., Ltd. (2 510(k)s)
- Suzhou Colour-Way Enterprise Development Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Suzhou Master Machinery Manufacturing Co.,Ltd?
FDA lists 6 510(k) clearances under the applicant name “Suzhou Master Machinery Manufacturing Co.,Ltd” (first 2023, latest 2026), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Suzhou Master Machinery Manufacturing Co.,Ltd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Suzhou Master Machinery Manufacturing Co.,Ltd is 88 days. Since 2017: 88 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Suzhou Master Machinery Manufacturing Co.,Ltd?
The most frequent FDA product codes under this applicant name are INI (Vehicle, Motorized 3-Wheeled, 3); ITI (Wheelchair, Powered, 2); IOR (Wheelchair, Mechanical, 1).
Next steps
- See all 6 Suzhou Master Machinery Manufacturing Co.,Ltd clearances with predicates and recalls
- Run predicate analysis for product code INI, Suzhou Master Machinery Manufacturing 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.