Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Health Hero Network, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
64 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080091 | MODIFICATION TO:HEALTH BUDDY APPLIANCE | Health Hero Network, Inc. | 2008-02-05 | 22 | 0 |
| K070543 | MODIFICATION TO HEALTH BUDDY APPLIANCE | Health Hero Network, Inc. | 2007-03-28 | 30 | 0 |
| K063612 | MODIFICATION TO HEALTH BUDDY APPLIANCE | Health Hero Network, Inc. | 2006-12-29 | 25 | 0 |
| K060843 | MODIFICATION TO HEALTH BUDDY APPLIANCE | Health Hero Network, Inc. | 2006-04-20 | 23 | 0 |
| K050567 | HEALTH BUDDY APPLIANCE | Health Hero Network, Inc. | 2005-04-05 | 32 | 0 |
| K042273 | MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY | Health Hero Network, Inc. | 2004-08-31 | 8 | 0 |
| K040086 | HEALTH BUDDY WITH BUDDYLINK | Health Hero Network, Inc. | 2004-03-10 | 54 | 0 |
| K993128 | HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER] | Health Hero Network, Inc. | 1999-11-23 | 64 | 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