Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advance Medical Device, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
504 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964697 | AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION | Advance Medical Device, Inc. | 1997-02-11 | 81 | 0 |
| K943200 | FLOSCOPE SUPER VASCULAR LAB | Advance Medical Device, Inc. | 1995-11-21 | 504 | 0 |
| K910441 | FLOSCOPE MICRODOP | Advance Medical Device, Inc. | 1991-03-21 | 49 | 0 |
| K905157 | FLOSCOPE VASCULAR LAB. | Advance Medical Device, Inc. | 1991-03-15 | 119 | 0 |
| K903744 | PHYSICIAN'S CHOICE | Advance Medical Device, Inc. | 1990-09-12 | 27 | 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