Jiangsu Caina Medical Co.,Ltd: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Jiangsu Caina Medical Co.,Ltd” (first 2018, latest 2024), across 10 product codes in 4 review panels. Median 510(k) review time under this name: 178 days. Since 2017 the median was 178 days, against 183 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 | 2 | 232 |
| 2019 | 2 | 139 |
| 2020 | 3 | 247 |
| 2021 | 4 | 198 |
| 2022 | 1 | 178 |
| 2023 | 1 | 87 |
| 2024 | 2 | 145 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Jiangsu Caina Medical Co.,Ltd took a median 178 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 183 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMF | Syringe, Piston | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 2 | 2 |
| MEG | Syringe, Antistick | 2 | 2 |
| PNR | Enteral Syringes With Enteral Specific Connectors | 2 | 2 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| PIO | Enteral Specific Transition Connectors | 1 | 1 |
| PTI | Non-Coring (Huber) Needle | 1 | 1 |
| QEH | Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact | 1 | 1 |
Review panels
Most recent Jiangsu Caina Medical Co.,Ltd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232781 | Safety Sliding Blood Collection Set | JKA | 2024-03-07 | 178 |
| K233190 | ENFit Adaptor | PIO | 2024-01-18 | 112 |
| K230635 | Pen Needle | FMI | 2023-06-02 | 87 |
| K220184 | Pump Alignment Syringe | FMF | 2022-07-21 | 178 |
| K211593 | Enteral Pump Syringe | PNR | 2021-09-30 | 129 |
| K210217 | Needleless Connector | FPA | 2021-05-17 | 110 |
| K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion Set | PTI | 2021-04-07 | 407 |
| K201356 | Plastic LOR Syringe | CAZ | 2021-02-12 | 267 |
| K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter | JKA | 2020-09-09 | 247 |
| K193022 | Retractable Safety Insulin Syringe | MEG | 2020-07-20 | 264 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Jiangsu Caina 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.
- 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 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 Caina Medical Co.,Ltd?
FDA lists 15 510(k) clearances under the applicant name “Jiangsu Caina Medical Co.,Ltd” (first 2018, latest 2024), across 10 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 Caina Medical Co.,Ltd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jiangsu Caina Medical Co.,Ltd is 178 days. Since 2017: 178 days, versus 183 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Jiangsu Caina Medical Co.,Ltd?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 2); FMI (Needle, Hypodermic, Single Lumen, 2); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 2).
Next steps
- See all 15 Jiangsu Caina Medical Co.,Ltd clearances with predicates and recalls
- Run predicate analysis for product code FMF, Jiangsu Caina 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.