Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hoana Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
148 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100745 | LIFEBED NETWORK PATIENT VIGILANCE SYSTEM | Hoana Medical, Inc. | 2010-04-15 | 30 | 0 |
| K092037 | LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM | Hoana Medical, Inc. | 2009-10-02 | 88 | 0 |
| K083534 | LIFEBED NETWORK PATIENT VIGILANCE SYSTEM | Hoana Medical, Inc. | 2009-04-13 | 136 | 0 |
| K082366 | LIFEBED PATIENT VIGILANCE SYSTEM | Hoana Medical, Inc. | 2008-09-26 | 39 | 0 |
| K052446 | LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM | Hoana Medical, Inc. | 2006-02-02 | 148 | 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