Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FWX · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K884019 | ALM OPERATING TABLES | Alm Surgical Equipment, Inc. | 1988-10-13 | 21 | 0 |
| K841116 | MOBILE OPHTHALMIC OPERATING TABLE | Surgi-Quip Inc.U | 1984-05-09 | 55 | 0 |
| K821923 | TABLE, OPERATING, FIELD 6530-00-709-8175 | Emerson-Sack-Warner Corp. | 1982-07-13 | 14 | 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