Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Calnor of EL Paseo, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
109 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841895 | GSR, 126, EEG 130-TEMP. 132, EMG 133 | Calnor of EL Paseo, Inc. | 1984-07-17 | 71 | 0 |
| K842288 | EEG 130 | Calnor of EL Paseo, Inc. | 1984-07-17 | 71 | 0 |
| K842353 | TEMPERATURE 132 | Calnor of EL Paseo, Inc. | 1984-07-17 | 71 | 0 |
| K842354 | EMG MODEL 133 | Calnor of EL Paseo, Inc. | 1984-07-17 | 71 | 0 |
| K834152 | ETHYLENE OXIDE DETECTOR GLD-1-07 | Calnor of EL Paseo, Inc. | 1984-03-19 | 109 | 0 |
| K771577 | CLINICAL EMG MODEL 133 | Calnor of EL Paseo, Inc. | 1977-08-26 | 8 | 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