Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Goldway (Us), 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) |
|---|---|---|---|---|---|
| K112877 | COMEN MULTI-PARAMETER PATIENT MONITOR | Goldway (Us), Inc. | 2012-11-07 | 404 | 0 |
| K033988 | GOLDWAY UT4000A VITAL SIGNS MONITOR | Goldway (Us), Inc. | 2004-02-25 | 64 | 0 |
| K021154 | GOLDWAY PATIENT MONITOR, MODEL # UT4000F | Goldway Us, Inc. | 2003-04-11 | 366 | 0 |
| K021153 | GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC- | Goldway Us, Inc. | 2003-02-10 | 306 | 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