Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LRH — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962609 | GRAM NEGATIVE IDENTIFICATION PLUS CARD | Biomerieux Vitek, Inc. | 1996-08-30 | 58 | 0 |
| K961042 | MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL | Dade Microscan, Inc. | 1996-05-30 | 77 | 0 |
| K926248 | READER | Alamar Biosciences Laboratory, Inc. | 1994-05-17 | 519 | 0 |
| K920225 | AUTOSCEPTOR IDENTIFICATION SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-05-22 | 126 | 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