Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Healthscan Products, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
119 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962924 | PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM | Healthscan Products, Inc. | 1996-10-25 | 88 | 0 |
| K962929 | PERSONAL BEST II | Healthscan Products, Inc. | 1996-10-24 | 87 | 0 |
| K962822 | OPTICHAMBER | Healthscan Products, Inc. | 1996-10-17 | 90 | 0 |
| K961077 | PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE | Healthscan Products, Inc. | 1996-07-15 | 119 | 0 |
| K933889 | PERSONAL BEST LOW RANGE | Healthscan Products, Inc. | 1993-09-09 | 30 | 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