Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LCA — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
59 daysmedian FDA review time
133 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880291 | THEOPHYLLINE TEST KIT REF. #A874799 | Photec Diagnostics, Inc. | 1988-03-24 | 59 | 0 |
| K833789 | PHASE II THEOPHYLLINE RADIOIMMUNOASSAY | Medical & Scientific Designs, Inc. | 1984-01-24 | 85 | 0 |
| K821862 | QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. | Kallestad Laboratories, Inc. | 1982-07-06 | 12 | 0 |
| K821347 | BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. | Bioclinical Corp. | 1982-05-28 | 23 | 0 |
| K792062 | THEOPHYLLINE RIASSAY | Ria Diagnostics | 1980-02-25 | 133 | 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