Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LCE — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
22 daysmedian FDA review time
122 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K833715 | EMIT NETILMICIN ASSAY | Syva Co. | 1983-12-27 | 67 | 0 |
| K832088 | AMES TDA NETILMICIN TEST & SERUM | Miles Laboratories, Inc. | 1983-10-28 | 122 | 0 |
| K822941 | NETILMICIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1982-10-26 | 22 | 0 |
| K821698 | TDX NETILMICIN | Abbott Laboratories | 1982-06-22 | 14 | 0 |
| K821399 | MACRO-VUE CARD TEST, NETILMICIN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-05-28 | 17 | 0 |
| K820324 | EMIT AND NETILMICIN ASSAY | Syva Co. | 1982-02-23 | 18 | 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