Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FWY · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883457 | ASST-3000 SPINAL SURGERY TABLE | Orthopedic Systems, Inc. | 1988-08-26 | 14 | 0 |
| K873478 | SKYTRON MODEL 130 SURGICAL TABLE | Skytron, Div. the Kmw Group, Inc. | 1987-09-24 | 31 | 0 |
| K833509 | CHEMONUCLEOLYSIS TABLE | Stryker Corp. | 1983-11-28 | 48 | 0 |
| K800118 | CHICK SURGICAL TABLE | Warner-Lambert Co. | 1980-02-05 | 18 | 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