Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
United Pacific Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
66 daysmedian FDA review time
90 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003010 | SPIRIT ACUPUNCTURE NEEDLE | United Pacific Co., Ltd. | 2000-10-19 | 23 | 0 |
| K001718 | MILLENNIA ACUPUNCTURE NEEDLE | United Pacific Co., Ltd. | 2000-06-21 | 16 | 0 |
| K993123 | QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO | United Pacific Co., Ltd. | 1999-12-17 | 88 | 0 |
| K991503 | SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36 | United Pacific Co., Ltd. | 1999-07-28 | 90 | 0 |
| K990406 | KINGLI ACUPUNCTURE NEEDLE | United Pacific Co., Ltd. | 1999-04-16 | 66 | 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