Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Health Scan, 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) |
|---|---|---|---|---|---|
| K952909 | AUTOZONE | Health Scan, Inc. | 1996-03-29 | 280 | 0 |
| K842634 | PFLEX RESPIRATORY MUSCLE EXERCISER | Health Scan, Inc. | 1984-08-10 | 35 | 0 |
| K820528 | PFLEX TM | Health Scan, Inc. | 1982-03-26 | 25 | 0 |
| K820032 | VIT-O-METER | Health Scan, Inc. | 1982-02-10 | 35 | 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