Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Enraf-Nonius, B.V. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
156 daysmedian FDA review time
268 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251083 | Compact II | Enraf-Nonius, B.V. | 2025-09-12 | 156 | 0 |
| K243112 | Curapuls 670 | Enraf-Nonius, B.V. | 2025-06-25 | 268 | 0 |
| K230472 | Sonopuls 190 | Enraf-Nonius, B.V. | 2023-10-24 | 244 | 0 |
| K151640 | ELTRAC 471 | Enraf-Nonius, B.V. | 2015-10-16 | 120 | 0 |
| K030297 | FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 146027 | Enraf-Nonius, B.V. | 2003-04-28 | 90 | 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