U&U Medical Technology Co, Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “U&U Medical Technology Co, Ltd.” (first 2013, latest 2019), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 218 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 |
|---|---|---|
| 2013 | 1 | 91 |
| 2014 | 2 | 351 |
| 2015 | 3 | 148 |
| 2016 | 2 | 209 |
| 2017 | 0 | — |
| 2018 | 1 | 248 |
| 2019 | 1 | 251 |
| 2020 | 0 | — |
| 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 U&U Medical Technology Co, Ltd. took a median 250 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 175 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| FRG | Wrap, Sterilization | 2 | 2 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 2 | 2 |
| FMF | Syringe, Piston | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| MEG | Syringe, Antistick | 1 | 1 |
| PNR | Enteral Syringes With Enteral Specific Connectors | 1 | 1 |
Review panels
Most recent U&U Medical Technology Co, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181508 | U&U Blood Collection Sets | FMI | 2019-02-13 | 251 |
| K171823 | U&U Indicator tape and strip | JOJ | 2018-02-22 | 248 |
| K160855 | U&U Enteral Syringe | PNR | 2016-11-22 | 239 |
| K152808 | U&U Insulin Syringe with/without Safety Retractable Device | MEG | 2016-03-25 | 179 |
| K151151 | U & U Intravascular Administration Set | FPA | 2015-09-24 | 147 |
| K143637 | U&U Sterilization Pouch and Roll | FRG | 2015-09-09 | 261 |
| K143629 | U&U Bowie-Dick Test Pack | JOJ | 2015-05-19 | 148 |
| K132553 | U&U STERILE PISTON SYRINGE WITHOUT NEEDLE | FMF | 2014-02-27 | 197 |
| K123162 | U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL | FRG | 2014-02-26 | 505 |
| K132552 | U&U STERILE HYPODERMIC NEEDLE | FMI | 2013-11-13 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named U&U 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under U&U Medical Technology Co, Ltd.?
FDA lists 10 510(k) clearances under the applicant name “U&U Medical Technology Co, Ltd.” (first 2013, latest 2019), across 7 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 U&U Medical Technology Co, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name U&U Medical Technology Co, Ltd. is 218 days.
Which FDA product codes appear under U&U Medical Technology Co, Ltd.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 2); FRG (Wrap, Sterilization, 2); JOJ (Indicator, Physical/Chemical Sterilization Process, 2).
Next steps
- See all 10 U&U Medical Technology Co, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FMI, U&U 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.