B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.” (first 2011, latest 2021), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 106 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 2 | 166 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 106 |
| 2021 | 1 | 109 |
| 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 B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. took a median 108 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GDW | Staple, Implantable | 3 | 3 |
| FXX | Mask, Surgical | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
Review panels
Most recent B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202843 | Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) | FXX | 2021-01-12 | 109 |
| K202706 | Surgical Gown (Sterile), Surgical Gown (Non-sterile) | FYA | 2020-12-31 | 106 |
| K152618 | PANTHER Cutter Stapler | GDW | 2015-11-12 | 59 |
| K142577 | PANTHER Endo Linear Cutter Staplers with Single Use Loading Units | GDW | 2015-06-11 | 272 |
| K103470 | PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP | GDW | 2011-01-11 | 46 |
Recalls
openFDA lists no recalls under a recalling firm named B.J.ZH.F.PANTHER MEDICAL EQUIPMENT 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.” (first 2011, latest 2021), across 3 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 B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. is 106 days.
Which FDA product codes appear under B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.?
The most frequent FDA product codes under this applicant name are GDW (Staple, Implantable, 3); FXX (Mask, Surgical, 1); FYA (Gown, Surgical, 1).
Next steps
- See all 5 B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GDW, B.J.ZH.F.PANTHER MEDICAL EQUIPMENT 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.