Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Simplicity Diagnostics, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
122 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970100 | TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK S | Simplicity Diagnostics, Inc. | 1997-03-10 | 59 | 0 |
| K922722 | TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL | Simplicity Diagnostics, Inc. | 1992-10-05 | 122 | 0 |
| K922725 | TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL | Simplicity Diagnostics, Inc. | 1992-10-05 | 122 | 0 |
| K922726 | TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL | Simplicity Diagnostics, Inc. | 1992-10-05 | 122 | 0 |
| K922723 | TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL | Simplicity Diagnostics, Inc. | 1992-09-18 | 105 | 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