Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neks Technologies, Inc. — Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063321 | D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 | Neks Technologies, Inc. | 2007-03-30 | 148 | 0 |
| K043156 | D-CARIE, MODEL N121-M1 | Neks Technologies, Inc. | 2005-04-28 | 164 | 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