Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Norav Medical , Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110463 | PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) | Norav Medical , Ltd. | 2011-11-10 | 266 | 0 |
| K080141 | PC ECG 1200W SYSTEM | Norav Medical , Ltd. | 2008-04-25 | 94 | 0 |
| K012712 | NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 | Norav Medical , Ltd. | 2002-05-08 | 267 | 0 |
| K000404 | PC ECG 1200 | Norav Medical , Ltd. | 2000-11-22 | 289 | 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