Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LBW · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
21 daysmedian FDA review time
56 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K904433 | DUAL LUMEN NEEDLES | Akcess Medical Products, Inc. | 1990-11-23 | 56 | 0 |
| K864629 | MODIFIED DUAL LUMEN NEEDLE | Quinton, Inc. | 1986-12-16 | 21 | 0 |
| K860515 | DUAL LUMEN NEEDLE (PRODUCT CHANGE) | Quinton, Inc. | 1986-03-04 | 21 | 0 |
| K820859 | COAXIAL DUAL FLOW CATHETER | Terumo Medical Corp. | 1982-04-16 | 18 | 0 |
| K801968 | HEMOCATH I KIDNEY DIALYSIS CATHETER | Medical Components, Inc. | 1980-09-26 | 38 | 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