Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Computer Dialysis Systems, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K850127 | FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G | Computer Dialysis Systems, Inc. | 1985-03-20 | 65 | 0 |
| K831132 | COMPUDIAL/KP-1 | Computer Dialysis Systems, Inc. | 1983-08-08 | 124 | 0 |
| K820575 | J.E.T. DIALYSIS SYSTEM | Computer Dialysis Systems, Inc. | 1982-05-20 | 78 | 0 |
| K813107 | COMPUDIAL/KP-1 | Computer Dialysis Systems, Inc. | 1982-03-23 | 140 | 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