Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Paragon Diagnostics, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
119 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841162 | IMMPULSE GENTAMICIN ASSAY REAGENTS | Paragon Diagnostics, Inc. | 1984-05-02 | 44 | 0 |
| K841161 | IMMPULSE AMIKACIN ASSAY REAGENTS | Paragon Diagnostics, Inc. | 1984-05-02 | 44 | 0 |
| K840852 | IMMPULSE T4 ASSAY REAGENTS | Paragon Diagnostics, Inc. | 1984-04-18 | 54 | 0 |
| K840847 | IMMPULSE TOBRAMYCIN ASSAY REAGENTS | Paragon Diagnostics, Inc. | 1984-04-04 | 40 | 0 |
| K840758 | IMMPULSE THEOPHYLLINE ASSAY REAGENTS | Paragon Diagnostics, Inc. | 1984-04-04 | 41 | 0 |
| K840853 | IMMPULSE TBC ASSAY REAGENTS | Paragon Diagnostics, Inc. | 1984-04-01 | 37 | 0 |
| K834070 | IMMPULSE SYSTEM | Paragon Diagnostics, Inc. | 1984-03-23 | 119 | 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