Jiangxi Hongda Medical Equipment Group , Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Jiangxi Hongda Medical Equipment Group , Ltd.” (first 2017, latest 2021), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 130 days. Since 2017 the median was 130 days, against 130 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 | 3 | 130 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 4 | 132 |
| 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 Jiangxi Hongda Medical Equipment Group , Ltd. took a median 130 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 130 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MEG | Syringe, Antistick | 2 | 2 |
| FMF | Syringe, Piston | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| LYZ | Vinyl Patient Examination Glove | 1 | 1 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (7)
Most recent Jiangxi Hongda Medical Equipment Group , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211753 | Sterile Syringe With Safety Needle | MEG | 2021-10-14 | 129 |
| K210622 | Single-Use Medical Face Mask | FXX | 2021-10-08 | 220 |
| K210578 | Medical Nitrile Examination Gloves (Power free, Blue) | LZA | 2021-07-10 | 134 |
| K210821 | Medical PVC Examination Gloves | LYZ | 2021-07-09 | 112 |
| K163160 | Sterile Single-use Infusion Set | FPA | 2017-04-20 | 161 |
| K163162 | Sterile Hypodermic Safety Syringes for Single Use | MEG | 2017-03-20 | 130 |
| K163161 | Sterile Single-use Syringe with Needle | FMF | 2017-03-20 | 130 |
Recalls
openFDA lists no recalls under a recalling firm named Jiangxi Hongda Medical Equipment Group , 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.
- Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. (3 510(k)s)
- Jiangxi Sanxin Medtec Co., Ltd. (3 510(k)s)
- Jiangxi Aicare Medical Technology Co., Ltd. (2 510(k)s)
- Jiangxi AOV Maternity & Baby Products Co., Ltd. (2 510(k)s)
- Jiangxi Handspro Products Solutions Co., Ltd. (2 510(k)s)
- Jiangxi Medex Technology Co., Ltd. (2 510(k)s)
- Jiangxi Sanhao Medical Instruments Co.,Ltd (2 510(k)s)
- Jiangxi Sanxin (Eversincere) Medical Devices Group (2 510(k)s)
- Jiangxi Yikang Medical Instrument Group Co., Ltd. (2 510(k)s)
- Jiangxi Zhonghong Pulin Medical Products Co., Ltd. (2 510(k)s)
- Jiangxi 3l Medical Products Group Co., Ltd. (1 510(k)s)
- Jiangxi Bestgrand Health Technology Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Jiangxi Hongda Medical Equipment Group , Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Jiangxi Hongda Medical Equipment Group , Ltd.” (first 2017, latest 2021), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Jiangxi Hongda Medical Equipment Group , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jiangxi Hongda Medical Equipment Group , Ltd. is 130 days. Since 2017: 130 days, versus 130 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Jiangxi Hongda Medical Equipment Group , Ltd.?
The most frequent FDA product codes under this applicant name are MEG (Syringe, Antistick, 2); FMF (Syringe, Piston, 1); FPA (Set, Administration, Intravascular, 1).
Next steps
- See all 7 Jiangxi Hongda Medical Equipment Group , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MEG, Jiangxi Hongda Medical Equipment Group , 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.