Shinva Ande Healthcare Apparatus Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Shinva Ande Healthcare Apparatus Co., Ltd.” (first 2017, latest 2022), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 284 days. Since 2017 the median was 284 days, against 205 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 |
|---|---|---|
| 2017 | 1 | 254 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 257 |
| 2021 | 1 | 361 |
| 2022 | 3 | 293 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shinva Ande Healthcare Apparatus Co., Ltd. took a median 284 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 205 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MEG | Syringe, Antistick | 2 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | 1 | 1 |
| PNR | Enteral Syringes With Enteral Specific Connectors | 1 | 1 |
Review panels
Most recent Shinva Ande Healthcare Apparatus Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201460 | Closed System Transfer Device | ONB | 2022-11-23 | 904 |
| K220057 | Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization | MEG | 2022-10-07 | 274 |
| K211484 | Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles | MEG | 2022-03-01 | 293 |
| K202060 | Disposable IV catheter | FOZ | 2021-07-23 | 361 |
| K193657 | Disposable Enteral Feeding Syringe with Enfit Connector | PNR | 2020-09-12 | 257 |
| K162601 | Infusion Set for Single Use | FPA | 2017-05-31 | 254 |
Recalls
openFDA lists no recalls under a recalling firm named Shinva Ande Healthcare Apparatus 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.
- Shinva Medical Instrument Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shinva Ande Healthcare Apparatus Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Shinva Ande Healthcare Apparatus Co., Ltd.” (first 2017, latest 2022), across 5 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 Shinva Ande Healthcare Apparatus Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shinva Ande Healthcare Apparatus Co., Ltd. is 284 days. Since 2017: 284 days, versus 205 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shinva Ande Healthcare Apparatus Co., Ltd.?
The most frequent FDA product codes under this applicant name are MEG (Syringe, Antistick, 2); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1); FPA (Set, Administration, Intravascular, 1).
Next steps
- See all 6 Shinva Ande Healthcare Apparatus Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MEG, Shinva Ande Healthcare Apparatus 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.