Hubdic Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Hubdic Co., Ltd.” (first 2003, latest 2020), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 152 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 | 48 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 513 |
| 2021 | 0 | — |
| 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 Hubdic Co., Ltd. took a median 513 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 210 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 5 | 5 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
Review panels
Most recent Hubdic Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191978 | Fever Garde | FLL | 2020-12-18 | 513 |
| K130361 | THERMOFINDER; THERMOCARE | FLL | 2013-04-02 | 48 |
| K101912 | THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301 | FLL | 2010-11-10 | 124 |
| K080636 | DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100 | CGA | 2009-02-13 | 344 |
| K043331 | DIGITAL FOREHEAD THERMOMETER, MODEL FS-100 | FLL | 2005-03-04 | 92 |
| K023412 | THERMO BUDDY, MODELS TB-100, TB-110, TB-120 | FLL | 2003-04-09 | 180 |
Recalls
openFDA lists no recalls under a recalling firm named Hubdic 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 Hubdic Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Hubdic Co., Ltd.” (first 2003, latest 2020), 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 Hubdic Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hubdic Co., Ltd. is 152 days.
Which FDA product codes appear under Hubdic Co., Ltd.?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 5); CGA (Glucose Oxidase, Glucose, 1).
Next steps
- See all 6 Hubdic Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FLL, Hubdic 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.