Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Elekon Industries U.S.A., Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
99 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042705 | DISPOSABLE NON-ADHESIVE SPO2 SENSORS | Elekon Industries U.S.A., Inc. | 2004-12-29 | 90 | 0 |
| K042675 | FLEXI-STAT SP02 EAR SENSOR | Elekon Industries U.S.A., Inc. | 2004-12-06 | 68 | 0 |
| K042704 | REUSABLE FINGER CLIP SPO2 SENSORS | Elekon Industries U.S.A., Inc. | 2004-11-26 | 57 | 0 |
| K041522 | FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS | Elekon Industries U.S.A., Inc. | 2004-09-14 | 99 | 0 |
| K041647 | FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPAT | Elekon Industries U.S.A., Inc. | 2004-09-02 | 77 | 0 |
| K041644 | FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-CO | Elekon Industries U.S.A., Inc. | 2004-07-29 | 42 | 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