Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bl Healthcare, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
26 daysmedian FDA review time
132 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113493 | TCX-I REMOTE CARE MANAGEMENT SYSTEM | Bl Healthcare, Inc. | 2011-12-21 | 26 | 0 |
| K101078 | BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM | Bl Healthcare, Inc. | 2010-05-10 | 21 | 0 |
| K093379 | TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM | Bl Healthcare, Inc. | 2010-02-09 | 103 | 0 |
| K052608 | TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM | Bl Healthcare, Inc. | 2006-02-01 | 132 | 0 |
| K051470 | REMOTE CARE MANAGEMENT SYSTEMS (RCMS) | Bl Healthcare, Inc. | 2005-06-08 | 5 | 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