Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clinical Systems, 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) |
|---|---|---|---|---|---|
| K921050 | ULTRAFLO RATESAVER PLUS INFUSION PUMP | Clinical Systems, Inc. | 1993-08-03 | 516 | 0 |
| K915061 | PROACT CLA-1500 SYSTEM | Clinical Systems, Inc. | 1992-01-31 | 84 | 0 |
| K901458 | NUTRICARE ENFUTEC 1000 ENTERAL FEEDING PUMP | Clinical Systems, Inc. | 1990-06-22 | 86 | 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