Coreleader Biotech Co., Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Coreleader Biotech Co., Ltd.” (first 2011, latest 2015), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 216 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 | 1 | 216 |
| 2014 | 0 | — |
| 2015 | 2 | 173 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 5 | 5 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 2 | 2 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 | 1 |
| MDA | Elastomer, Silicone, For Scar Management | 1 | 1 |
Review panels
Most recent Coreleader Biotech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151204 | HEMO-Bandage | QSY | 2015-07-31 | 87 |
| K141382 | BIOS KING BIOCELLULOSE FILM | FRO | 2015-02-10 | 259 |
| K123394 | CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING | FRO | 2013-06-06 | 216 |
| K111578 | CORELEADER COLLA-ALGI FIBER MODEL CAW | FRO | 2011-09-23 | 108 |
| K111733 | CORELEADER SCAR-DIMMER | MDA | 2011-09-22 | 93 |
| K102944 | CORELEADER HEMO-PAD MODEL CPII 02030 | QSY | 2011-09-07 | 338 |
| K102942 | CORELEADER ALGIPLASTER MODEL AP 050501 | FRO | 2011-06-22 | 261 |
| K102946 | CORELEADER COLLA-PAD MODEL CS 03030 | KGN | 2011-05-20 | 228 |
| K102943 | CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 | FRO | 2011-04-12 | 190 |
Recalls
openFDA lists no recalls under a recalling firm named Coreleader Biotech 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 Coreleader Biotech Co., Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Coreleader Biotech Co., Ltd.” (first 2011, latest 2015), across 4 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 Coreleader Biotech Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Coreleader Biotech Co., Ltd. is 216 days.
Which FDA product codes appear under Coreleader Biotech Co., Ltd.?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 5); QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics, 2); KGN (Wound Dressing With Animal-Derived Material(S), 1).
Next steps
- See all 9 Coreleader Biotech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Coreleader Biotech 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.