Ningbo Medsun Medical Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Ningbo Medsun Medical Co., Ltd.” (first 2022, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 94 days. Since 2017 the median was 94 days, against 116 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 |
|---|---|---|
| 2022 | 2 | 142 |
| 2023 | 0 | — |
| 2024 | 3 | 57 |
| 2025 | 0 | — |
| 2026 | 2 | 107 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ningbo Medsun Medical Co., Ltd. took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 4 | 4 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | 1 | 1 |
Review panels
Most recent Ningbo Medsun Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253622 | Safety Pen Needle | FMI | 2026-03-18 | 120 |
| K253605 | Safety Heel Lancet | FMK | 2026-02-20 | 94 |
| K242627 | Safety Lancet | FMK | 2024-10-30 | 57 |
| K242316 | Safety Lancet | FMK | 2024-08-28 | 23 |
| K232330 | Lancing System | QRK | 2024-01-04 | 154 |
| K221178 | Disposable Insulin Pen Needle | FMI | 2022-11-17 | 206 |
| K222090 | Safety Lancet | FMK | 2022-09-30 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Ningbo Medsun Medical 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.
- Ningbo Maxcon Medical Technology Co., Ltd. (4 510(k)s)
- Ningbo Ranor Medical Science & Technology Co., Ltd. (4 510(k)s)
- Ningbo Shenyu Medical Equipment Co.,Ltd (4 510(k)s)
- Ningbo Youhe Electrical Appliance Technology Co., Ltd. (4 510(k)s)
- Ningbo Yujiang Plastic & Rubber Co. , Ltd. (4 510(k)s)
- Ningbo Baichen Medical Devices Co., Ltd. (3 510(k)s)
- Ningbo Diaier Electronic Co., Ltd. (3 510(k)s)
- Ningbo Tianyi Medical Appliance Co., Ltd. (3 510(k)s)
- Ningbo Albert Novosino Co., Ltd. (2 510(k)s)
- Ningbo Caremed Medical Products Co., Ltd. (2 510(k)s)
- Ningbo Dizegens Medical Science Co.,Ltd (2 510(k)s)
- Ningbo Jingeao Electronics, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ningbo Medsun Medical Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Ningbo Medsun Medical Co., Ltd.” (first 2022, latest 2026), across 3 product codes in 2 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 Ningbo Medsun Medical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ningbo Medsun Medical Co., Ltd. is 94 days. Since 2017: 94 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ningbo Medsun Medical Co., Ltd.?
The most frequent FDA product codes under this applicant name are FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, 4); FMI (Needle, Hypodermic, Single Lumen, 2); QRK (Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature, 1).
Next steps
- See all 7 Ningbo Medsun Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FMK, Ningbo Medsun Medical 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.