Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FIQ — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
34 daysmedian FDA review time
101 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K892887 | ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA | Akcess Medical Products, Inc. | 1989-05-15 | 25 | 0 |
| K892663 | S-100 ALLEN-BROWN SHUNT | Akcess Medical Products, Inc. | 1989-05-04 | 21 | 0 |
| K892666 | SAF-T-SHUNT, S-300 SERIES | Akcess Medical Products, Inc. | 1989-05-04 | 21 | 0 |
| K844692 | PEDIATRIC SIZED HEMOCATH CATHETER | Quinton, Inc. | 1985-01-18 | 46 | 0 |
| K841791 | PLUME FISTULA NEEDLE | Hospal Medical Corp. | 1984-07-09 | 70 | 0 |
| K840322 | HEMOFILTRATION CATHETER HF-100 | Vas-Cath of Canada , Ltd. | 1984-04-24 | 90 | 0 |
| K840415 | HEMOCATH | Quinton, Inc. | 1984-04-20 | 80 | 0 |
| K834358 | PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA | Vas-Cath of Canada , Ltd. | 1984-04-02 | 111 | 0 |
| K840436 | HEMASITE/RENALOY -VASCULAR ACCESS SHUNT | Renal Systems, Inc. | 1984-02-21 | 20 | 0 |
| K833622 | RENALLOY HEMASITE VASCULAR ACCESS SHUNT | Renal Systems, Inc. | 1983-11-29 | 46 | 0 |
| K831801 | HEMOCLAV VENOUS CATHETER | Exo, Inc. | 1983-07-07 | 34 | 0 |
| K831401 | SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS | Med-West, Inc. | 1983-06-03 | 32 | 0 |
| K831440 | SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 | Med-West, Inc. | 1983-06-03 | 29 | 0 |
| K823752 | EXTRACORPOREAL SUBCLAVIAN CATHETER KIT | Extracorporeal Medical Specialities, Inc. | 1983-01-14 | 31 | 0 |
| K822880 | ARTERIO VENOUS SHUNT CANNULA & ADAPTORS | Renal Systems, Inc. | 1982-10-18 | 27 | 0 |
| K813237 | HEMASITE VASCULAR ACCESS SHUNT HM-1000 | Renal Systems, Inc. | 1981-11-30 | 20 | 0 |
| K812890 | HEMASITE GRAFTLESS VASCULAR ACESS | Renal Systems, Inc. | 1981-11-16 | 32 | 0 |
| K811384 | HEMASITE VASCULAR ACCESS SHUNT | Renal Systems, Inc. | 1981-07-31 | 73 | 0 |
| K810114 | VASCULAR ACCESS SYSTEM | Bentley Laboratories, Inc. | 1981-03-26 | 101 | 0 |
| K801478 | SSC8 SORENSON SUBCLAVIAN CATHETER | Sorensen Research | 1980-08-27 | 64 | 0 |
| K791308 | ULDALL SUBCLAVIAN CANNULA SC-100 | Vas-Cath of Canada , Ltd. | 1979-08-03 | 18 | 0 |
| K780484 | SILASTIC BRAND PENILE IMPLANT | Dow Corning Corp. Healthcare Industries Materials | 1978-07-17 | 112 | 0 |
| K760973 | HEMODIALYSIS CANNULA & FEMORAL CLAMP | Rodell Medical, Inc. | 1977-01-12 | 70 | 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