Hebei Titans Hongsen Medical Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Hebei Titans Hongsen Medical Technology Co., Ltd.” (first 2018, latest 2024), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 85 days. Since 2017 the median was 85 days, against 119 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 | 78 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 70 |
| 2022 | 1 | 167 |
| 2023 | 1 | 85 |
| 2024 | 1 | 58 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hebei Titans Hongsen Medical Technology Co., Ltd. took a median 85 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | 2 | 2 |
| LZA | Polymer Patient Examination Glove | 2 | 2 |
| FXX | Mask, Surgical | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (7)
Most recent Hebei Titans Hongsen Medical Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240361 | Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL) | LZA | 2024-04-04 | 58 |
| K223895 | Disposable Medical Nitrile Examination Gloves | LZA | 2023-03-23 | 85 |
| K221374 | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) | LYY | 2022-10-26 | 167 |
| K212097 | Disposable medical surgical mask | FXX | 2021-08-18 | 43 |
| K211229 | Vinyl compound examination gloves | LYZ | 2021-07-29 | 97 |
| K182043 | Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) | LYZ | 2018-09-21 | 53 |
| K181130 | Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs | LZC | 2018-08-10 | 102 |
Recalls
openFDA lists no recalls under a recalling firm named Hebei Titans Hongsen Medical Technology 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.
- Hebei Hongsen Plastics Technology Co, Ltd. (5 510(k)s)
- Hebei Handform Plastic Products Co., Ltd. (4 510(k)s)
- Hebei JT Medical Co., Ltd. (3 510(k)s)
- Hebei Keylaser Sci-Tech Co.,Ltd (3 510(k)s)
- Hebei Zhemai Technology Co., Ltd. (3 510(k)s)
- Hebei Astro Medical Supply Co., Ltd. (2 510(k)s)
- Hebei Excellent Plastic Co., Ltd. (2 510(k)s)
- Hebei Hongtai Plastic Products Co., Ltd. (2 510(k)s)
- Hebei Manful Import & Export Co., Ltd. (2 510(k)s)
- Hebei Newangie Technology Co., Ltd. (2 510(k)s)
- Hebei Shenzichen Plastic & Rubber Products Co., LT (2 510(k)s)
- Hebei Tengda Plastic Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hebei Titans Hongsen Medical Technology Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Hebei Titans Hongsen Medical Technology Co., Ltd.” (first 2018, latest 2024), 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 Hebei Titans Hongsen Medical Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hebei Titans Hongsen Medical Technology Co., Ltd. is 85 days. Since 2017: 85 days, versus 119 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hebei Titans Hongsen Medical Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are LYZ (Vinyl Patient Examination Glove, 2); LZA (Polymer Patient Examination Glove, 2); FXX (Mask, Surgical, 1).
Next steps
- See all 7 Hebei Titans Hongsen Medical Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, Hebei Titans Hongsen Medical Technology 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.