Shantou Wealy Medical Instrument Co.,Ltd: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Shantou Wealy Medical Instrument Co.,Ltd” (first 2012, latest 2022), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 187 days. Since 2017 the median was 240 days, against 209 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 |
|---|---|---|
| 2012 | 1 | 81 |
| 2013 | 0 | — |
| 2014 | 1 | 153 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 240 |
| 2022 | 2 | 250 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shantou Wealy Medical Instrument Co.,Ltd took a median 240 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 209 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MEG | Syringe, Antistick | 4 | 4 |
| PNR | Enteral Syringes With Enteral Specific Connectors | 2 | 2 |
Review panels
Most recent Shantou Wealy Medical Instrument Co.,Ltd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle) | MEG | 2022-11-23 | 100 |
| K210216 | Disposable Automatically Retractable Insulin Safety Syringe | MEG | 2022-03-04 | 401 |
| K203613 | ENFit Reusable Enteral Syringe | PNR | 2021-08-27 | 260 |
| K203410 | ENFit Disposable Enteral Syringe | PNR | 2021-06-28 | 221 |
| K141640 | AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE | MEG | 2014-11-19 | 153 |
| K113587 | AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) | MEG | 2012-02-24 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named Shantou Wealy Medical Instrument 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.
- Shantou Institute of Ultrasonic Instuments (11 510(k)s)
- Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) (8 510(k)s)
- Shantou Institute of Ultrasonic Instruments (Siui (5 510(k)s)
- Shantou Institute of Ultrasonic Instruments Co., Ltd. (3 510(k)s)
- Shantou Xinghe Electrical Apparatuses Co., Ltd. (2 510(k)s)
- Shantou Huihengqi Electronic Technology Co., Ltd. (1 510(k)s)
- Shantou T&K Medical Equipment Factory Co.,Ltd (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shantou Wealy Medical Instrument Co.,Ltd?
FDA lists 6 510(k) clearances under the applicant name “Shantou Wealy Medical Instrument Co.,Ltd” (first 2012, latest 2022), across 2 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 Shantou Wealy Medical Instrument Co.,Ltd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shantou Wealy Medical Instrument Co.,Ltd is 187 days. Since 2017: 240 days, versus 209 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shantou Wealy Medical Instrument Co.,Ltd?
The most frequent FDA product codes under this applicant name are MEG (Syringe, Antistick, 4); PNR (Enteral Syringes With Enteral Specific Connectors, 2).
Next steps
- See all 6 Shantou Wealy Medical Instrument Co.,Ltd clearances with predicates and recalls
- Run predicate analysis for product code MEG, Shantou Wealy Medical Instrument 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.