Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zoll Manufacturing Corporation · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190939 | ZOLL Arrhythmia Management Sysyem | Zoll Manufacturing Corporation | 2019-12-19 | 253 | 0 |
| K182093 | ZOLL ECG Analysis Software | Zoll Manufacturing Corporation | 2019-01-28 | 178 | 0 |
| K172510 | µCor Heart Failure and Arrhythmia Management System | Zoll Manufacturing Corporation | 2018-05-11 | 263 | 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