Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Us Asia Instruments, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964820 | MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15 | Us Asia Instruments, Inc. | 1997-02-28 | 88 | 0 |
| K964753 | MATRIX 3000 FLEXIBLE SPINE COIL | Us Asia Instruments, Inc. | 1997-02-11 | 76 | 0 |
| K964531 | PROFILE 70000 QUADRATURE VOLUME NECK COIL | Us Asia Instruments, Inc. | 1997-01-24 | 73 | 0 |
| K943440 | PROFILE 7000 C-SPINE COIL | Us Asia Instruments, Inc. | 1995-10-06 | 445 | 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