Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FID · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022068 | TUBING, DIALYSATE (AND CONNECTOR) | Molded Products, Inc. | 2002-09-23 | 90 | 0 |
| K010712 | DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES | Molded Products, Inc. | 2001-09-27 | 202 | 0 |
| K770299 | TYGON M-60/TYGON M-70 | Norton Performance Plastics Corp. | 1977-03-16 | 30 | 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