Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Arzco Medical Electronics, Inc. · 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) |
|---|---|---|---|---|---|
| K904943 | TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE | Arzco Medical Electronics, Inc. | 1991-04-26 | 176 | 0 |
| K905831 | ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH | Arzco Medical Electronics, Inc. | 1991-03-29 | 88 | 0 |
| K903136 | ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER | Arzco Medical Electronics, Inc. | 1991-01-18 | 185 | 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