Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zoe Medical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
126 daysmedian FDA review time
390 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200160 | 740 SafeSAT | Zoe Medical, Inc. | 2021-02-15 | 390 | 0 |
| K130740 | NIGHTINGALE MONITORING SYSTEM | Zoe Medical, Inc. | 2013-07-23 | 126 | 0 |
| K093802 | ULTRAVIEW DM3 MONITOR | Zoe Medical, Inc. | 2010-04-09 | 119 | 2 |
| K040012 | WELL@HOME SYSTEM | Zoe Medical, Inc. | 2004-04-02 | 88 | 1 |
| K001775 | ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM | Zoe Medical, Inc. | 2001-01-12 | 214 | 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