Bl Healthcare, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Bl Healthcare, Inc.” (first 2005, latest 2011), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 26 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 4 | 4 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 1 | 1 |
Review panels
Most recent Bl Healthcare, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113493 | TCX-I REMOTE CARE MANAGEMENT SYSTEM | DRG | 2011-12-21 | 26 |
| K101078 | BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM | DRG | 2010-05-10 | 21 |
| K093379 | TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM | KDI | 2010-02-09 | 103 |
| K052608 | TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS) | DRG | 2006-02-01 | 132 |
| K051470 | REMOTE CARE MANAGEMENT SYSTEMS (RCMS) | DRG | 2005-06-08 | 5 |
Recalls
openFDA lists no recalls under a recalling firm named Bl Healthcare, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bl Healthcare, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Bl Healthcare, Inc.” (first 2005, latest 2011), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bl Healthcare, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bl Healthcare, Inc. is 26 days.
Which FDA product codes appear under Bl Healthcare, Inc.?
The most frequent FDA product codes under this applicant name are DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency, 4); KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 1).
Next steps
- See all 5 Bl Healthcare, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRG, Bl Healthcare, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.