Weihai Hongyu Nonwoven Fabric Products Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Weihai Hongyu Nonwoven Fabric Products Co., Ltd.” (first 2012, latest 2022), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 98 days. Since 2017 the median was 88 days, against 128 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 | 267 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 329 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 88 |
| 2022 | 2 | 78 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Weihai Hongyu Nonwoven Fabric Products Co., Ltd. took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FYA | Gown, Surgical | 2 | 2 |
| FRG | Wrap, Sterilization | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Weihai Hongyu Nonwoven Fabric Products Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K214088 | Disposable Surgical Gown | FYA | 2022-04-12 | 105 |
| K220133 | Sterilization Wraps | FRG | 2022-03-10 | 51 |
| K213029 | Nitrile Examination Gloves (Powder free, Blue) | LZA | 2021-12-14 | 84 |
| K212807 | Surgical Masks | FXX | 2021-12-03 | 91 |
| K141324 | HONGYU DISPOSABLE SURGICAL DRAPES | KKX | 2015-04-14 | 329 |
| K120192 | DISPOSABLE SURGICAL GOWNS | FYA | 2012-10-16 | 267 |
Recalls
openFDA lists no recalls under a recalling firm named Weihai Hongyu Nonwoven Fabric Products 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.
- Weihai Dishang Medical Technology Co., Ltd. (2 510(k)s)
- Weihai Xingtai Packaging Products Co., Ltd. (2 510(k)s)
- Weihai Hongyu Medical Devices Co., Ltd. (1 510(k)s)
- Weihai Jierui Medical Products Co., Ltd. (1 510(k)s)
- Weihai Kangzhou Biotechnology Engineering Co., Ltd. (1 510(k)s)
- Weihai Shengjie Medical Technology Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Weihai Hongyu Nonwoven Fabric Products Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Weihai Hongyu Nonwoven Fabric Products Co., Ltd.” (first 2012, latest 2022), across 5 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 Weihai Hongyu Nonwoven Fabric Products Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Weihai Hongyu Nonwoven Fabric Products Co., Ltd. is 98 days. Since 2017: 88 days, versus 128 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Weihai Hongyu Nonwoven Fabric Products Co., Ltd.?
The most frequent FDA product codes under this applicant name are FYA (Gown, Surgical, 2); FRG (Wrap, Sterilization, 1); FXX (Mask, Surgical, 1).
Next steps
- See all 6 Weihai Hongyu Nonwoven Fabric Products Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FYA, Weihai Hongyu Nonwoven Fabric Products 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.