Jiangsu Micsafe Medical Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Jiangsu Micsafe Medical Technology Co., Ltd.” (first 2018, latest 2021), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 216 days. Since 2017 the median was 216 days, against 157 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 |
|---|---|---|
| 2018 | 1 | 133 |
| 2019 | 1 | 253 |
| 2020 | 0 | — |
| 2021 | 3 | 216 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Jiangsu Micsafe Medical Technology Co., Ltd. took a median 216 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 157 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MEG | Syringe, Antistick | 2 | 2 |
| FXX | Mask, Surgical | 1 | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
| PNR | Enteral Syringes With Enteral Specific Connectors | 1 | 1 |
Review panels
Most recent Jiangsu Micsafe Medical Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212019 | Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single | JKA | 2021-11-04 | 129 |
| K202570 | Insulin Syringe, Insulin Syringe with Safety Retractable | MEG | 2021-07-02 | 301 |
| K202205 | Surgical Face Mask | FXX | 2021-03-09 | 216 |
| K183665 | Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use | MEG | 2019-09-06 | 253 |
| K181426 | Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) | PNR | 2018-10-11 | 133 |
Recalls
openFDA lists no recalls under a recalling firm named Jiangsu Micsafe Medical Technology 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 Yuyue Medical Equipment & Supply 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 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 Micsafe Medical Technology Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Jiangsu Micsafe Medical Technology Co., Ltd.” (first 2018, latest 2021), across 4 product codes in 3 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 Micsafe Medical Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jiangsu Micsafe Medical Technology Co., Ltd. is 216 days. Since 2017: 216 days, versus 157 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Jiangsu Micsafe Medical Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are MEG (Syringe, Antistick, 2); FXX (Mask, Surgical, 1); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 1).
Next steps
- See all 5 Jiangsu Micsafe Medical Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MEG, Jiangsu Micsafe Medical Technology 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.