Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LFK — Predicate Candidate Screening
16 FDA 510(k) clearances under this product code; the 50 most recent screened below.
50 daysmedian FDA review time
171 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971897 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH | Medron, Inc. | 1997-10-21 | 152 | 0 |
| K914936 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET | Akcess Medical Products, Inc. | 1992-04-23 | 171 | 0 |
| K915215 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS | Akcess Medical Products, Inc. | 1992-03-27 | 130 | 0 |
| K891764 | FC-101 FEMORAL CATHETER GUIDE WIRE | Akcess Medical Products, Inc. | 1989-04-07 | 14 | 0 |
| K891763 | FC-100 FEMORAL CATHETER | Akcess Medical Products, Inc. | 1989-04-07 | 14 | 0 |
| K890717 | MODIFICATION HEMOFILTRATION CATHETER HF-100 | Vas-Cath, Inc. | 1989-04-05 | 51 | 0 |
| K880775 | CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY | Medsurg Industries, Inc. | 1988-07-25 | 150 | 0 |
| K882466 | VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER | Vas-Cath, Inc. | 1988-07-13 | 28 | 0 |
| K865096 | NEW SECOND FRENCH SIZE MAHURKAR CATHETER | Quinton, Inc. | 1987-02-18 | 50 | 0 |
| K863218 | CYTOSTATIC FILTRATION SET | Meadox Surgimed, Inc. | 1987-02-12 | 176 | 0 |
| K862771 | MEDCOMP C.A.V.H. CATHETER | Medical Components, Inc. | 1986-08-06 | 15 | 0 |
| K860810 | MEDCOMP'S FEMORAL VEIN CATHETERS | Medical Components, Inc. | 1986-04-08 | 35 | 0 |
| K854612 | ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 | Med-West, Inc. | 1986-01-03 | 46 | 0 |
| K831828 | TEFLON FEMORAL CATHETER MWI 100,10 & | Med-West, Inc. | 1983-07-07 | 30 | 0 |
| K830674 | MAHURKAR FEMORAL CATHETER | Quinton, Inc. | 1983-05-18 | 75 | 0 |
| K820237 | COBE ACUFLEX FSN, #15-208 | Cobe Laboratories, Inc. | 1982-03-10 | 41 | 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