Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Graseby Medical , Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
273 daysmedian FDA review time
633 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944721 | 9000 INFUSION PUMP | Graseby Medical , Ltd. | 1995-08-11 | 322 | 0 |
| K931318 | 3400 INFUSION PUMP | Graseby Medical , Ltd. | 1994-12-09 | 633 | 0 |
| K915270 | PATIENT CONTROLLED SYRINGE PUMP TYPE 3300 | Graseby Medical , Ltd. | 1992-08-24 | 273 | 0 |
| K912192 | 3100 INFUSION PUMP | Graseby Medical , Ltd. | 1992-02-14 | 273 | 0 |
| K912193 | 3000 INFUSION PUMP | Graseby Medical , Ltd. | 1992-02-14 | 273 | 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