Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FKY · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991003 | PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT R | Dayspring Medical, Inc. | 1999-06-09 | 76 | 0 |
| K862722 | TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE | Mercury Enterprises, Inc. | 1986-08-11 | 25 | 0 |
| K830002 | CAPD COLOR-GUARD SYSTEM PREPKIT | Abbott Laboratories | 1983-03-11 | 67 | 0 |
| K771428 | TENCKHOFF PERITONEAL TUBING ADAPT. | Quinton, Inc. | 1977-10-18 | 78 | 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