Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
G.W. Healthcare, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K831821 | PNEUMATIC/ELECTRIC/HYDRAULIC BED | G.W. Healthcare, Inc. | 1983-08-08 | 63 | 0 |
| K830559 | HEALTHCARE MODEL #175/176 BED SERIES | G.W. Healthcare, Inc. | 1983-03-09 | 14 | 0 |
| K812600 | GER 540, GER 541 MANUAL BED | G.W. Healthcare, Inc. | 1981-09-23 | 9 | 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