Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KNZ — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
36 daysmedian FDA review time
253 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K842039 | ARGON DUAL LUMEN HEMODIALYSIS, CATHETER | Argon Medical Corp. | 1985-01-29 | 253 | 0 |
| K844612 | ACUTE HEMODIALYSIS TRAYS | Packaging Technologies, Inc. | 1984-12-17 | 20 | 0 |
| K842864 | VACCESS FEMORAL CANNULA | Vas-Cath of Canada , Ltd. | 1984-08-08 | 16 | 0 |
| K842416 | DUO FLOW CATHETER-MC 54 | Medical Components, Inc. | 1984-07-26 | 36 | 0 |
| K841530 | DOUBLE LUMEN SUBLCAVIAN-FEMORAL | Medical Components, Inc. | 1984-06-25 | 83 | 0 |
| K841119 | TOPS DISPOS. INFUSION SET/HEMODIALYSIS | Top Surgical Manufacturers Co. | 1984-04-20 | 36 | 0 |
| K840424 | HEMOCATH REPAIR KIT | Quinton, Inc. | 1984-03-05 | 33 | 0 |
| K840437 | HEMASITE ACCESSORIES MODIFICATION | Renal Systems, Inc. | 1984-02-21 | 20 | 0 |
| K834510 | RENAFLO AVF SET FOR HEMODIALYSIS | Renal Systems, Inc. | 1984-02-04 | 45 | 0 |
| K833139 | ACUTE HEMODIALYSIS TRAYS | Intermed, Inc. | 1983-12-22 | 99 | 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