Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Aristo Medical Products, Inc. · 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) |
|---|---|---|---|---|---|
| K961060 | ARISTO ESOPHAGEAL STETHOSCOPE | Aristo Medical Products, Inc. | 1996-06-19 | 93 | 0 |
| K960251 | COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND | Aristo Medical Products, Inc. | 1996-03-26 | 68 | 0 |
| K953817 | ARISTO MEDICAL MODEL 2101 PATIENT MONITOR | Aristo Medical Products, Inc. | 1995-11-22 | 100 | 0 |
| K920966 | SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT) | Aristo Medical Products, Inc. | 1993-07-16 | 501 | 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