Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LIE — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
91 daysmedian FDA review time
317 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221493 | MicroScan Prompt Inoculation System-D | Beckman Coulter, Inc. | 2023-04-05 | 317 | 0 |
| K103456 | THE SENSITITRE AIM | Trek Diagnostic Systems | 2011-06-22 | 210 | 0 |
| K110331 | SENSITITRE AIM (TM) | Trek Diagnostic Systems, Ltd. | 2011-04-27 | 83 | 0 |
| K935566 | SENSI-CAL AMCO AEPA-1 | Radiometer America, Inc. | 1994-03-29 | 131 | 0 |
| K911059 | TURBIDOMETRIC STANDARD | Scientific Device Laboratory, Inc. | 1991-06-10 | 91 | 0 |
| K890339 | DIFCO DIRECTOR INOCULATION SYSTEM | Difco Laboratories, Inc. | 1989-02-07 | 15 | 0 |
| K820299 | PROMPT INOCULATION SYSTEM | 3M Company | 1982-03-15 | 39 | 2 |
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