Jiangsu Kangbao Medical Equipment Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Jiangsu Kangbao Medical Equipment Co., Ltd.” (first 2018, latest 2023), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 183 days. Since 2017 the median was 183 days, against 215 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 | 46 |
| 2019 | 0 | — |
| 2020 | 1 | 306 |
| 2021 | 1 | 196 |
| 2022 | 1 | 183 |
| 2023 | 1 | 95 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Jiangsu Kangbao Medical Equipment Co., Ltd. took a median 183 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 215 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MEG | Syringe, Antistick | 2 | 2 |
| FPA | Set, Administration, Intravascular | 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 Kangbao Medical Equipment Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232881 | Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder | JKA | 2023-12-22 | 95 |
| K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle | MEG | 2022-11-01 | 183 |
| K211329 | Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle | MEG | 2021-11-15 | 196 |
| K192681 | Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) | FPA | 2020-07-28 | 306 |
| K182649 | Enteral Feeding Syringes with Enfit Connectors | PNR | 2018-11-09 | 46 |
Recalls
openFDA lists no recalls under a recalling firm named Jiangsu Kangbao Medical Equipment 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 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 Kangbao Medical Equipment Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Jiangsu Kangbao Medical Equipment Co., Ltd.” (first 2018, latest 2023), 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 Kangbao Medical Equipment Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jiangsu Kangbao Medical Equipment Co., Ltd. is 183 days. Since 2017: 183 days, versus 215 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Jiangsu Kangbao Medical Equipment Co., Ltd.?
The most frequent FDA product codes under this applicant name are MEG (Syringe, Antistick, 2); FPA (Set, Administration, Intravascular, 1); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 1).
Next steps
- See all 5 Jiangsu Kangbao Medical Equipment Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MEG, Jiangsu Kangbao Medical Equipment 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.