Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ash Medical 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) |
|---|---|---|---|---|---|
| K874137 | MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR | Ash Medical Systems, Inc. | 1988-04-08 | 178 | 0 |
| K870270 | MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART. | Ash Medical Systems, Inc. | 1987-02-25 | 29 | 0 |
| K864179 | BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR | Ash Medical Systems, Inc. | 1986-12-11 | 48 | 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