Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
U&U Medical Technology Co, Ltd. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
239 daysmedian FDA review time
505 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181508 | U&U Blood Collection Sets | U&U Medical Technology Co, Ltd. | 2019-02-13 | 251 | 0 |
| K171823 | U&U Indicator tape and strip | U&U Medical Technology Co, Ltd. | 2018-02-22 | 248 | 0 |
| K160855 | U&U Enteral Syringe | U&U Medical Technology Co, Ltd. | 2016-11-22 | 239 | 0 |
| K152808 | U&U Insulin Syringe with/without Safety Retractable Device | U&U Medical Technology Co, Ltd. | 2016-03-25 | 179 | 0 |
| K151151 | U & U Intravascular Administration Set | U&U Medical Technology Co, Ltd. | 2015-09-24 | 147 | 0 |
| K143637 | U&U Sterilization Pouch and Roll | U&U Medical Technology Co, Ltd. | 2015-09-09 | 261 | 0 |
| K143629 | U&U Bowie-Dick Test Pack | U&U Medical Technology Co, Ltd. | 2015-05-19 | 148 | 0 |
| K132553 | U&U STERILE PISTON SYRINGE WITHOUT NEEDLE | U&U Medical Technology Co, Ltd. | 2014-02-27 | 197 | 1 |
| K123162 | U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL | U&U Medical Technology Co, Ltd. | 2014-02-26 | 505 | 0 |
| K132552 | U&U STERILE HYPODERMIC NEEDLE | U&U Medical Technology Co, Ltd. | 2013-11-13 | 91 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda