510(k) Report

FDA applicant

Bl Healthcare, Inc.

Foxboro, MA5 decisions2005–20110 recalls

FDA records 5 decisions for Bl Healthcare, Inc. (Foxboro, MA) from 2005 to 2011: 5 510(k) clearances. Most are in product codes DRG (Transmitters And Receivers, Physiological…) and KDI (Dialyzer, High Permeability With Or Without…). Its devices cite 20 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Bl Healthcare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2010: 22011: 1
2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bl Healthcare, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bl Healthcare, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency4decisions
  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System1decision

Whose devices does it build on?

Its devices cite 20 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K051470Remote Care Management Systems (RCMS)Bl Healthcare, Inc. · 20059cite it
  • K093379TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 20102cite it
  • K052608Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc. · 20062cite it
  • K101078BL Healthcare Remote Care Management SystemBl Healthcare, Inc. · 20101cites it

What has FDA decided for it lately?

  • K113493TCX-I Remote Care Management SystemBl Healthcare, Inc. · 2011
  • K101078BL Healthcare Remote Care Management SystemBl Healthcare, Inc. · 2010
  • K093379TCX-I-DV Remote Care Management SystemBl Healthcare, Inc. · 2010
  • K052608Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc. · 2006
  • K051470Remote Care Management Systems (RCMS)Bl Healthcare, Inc. · 2005

All 5 as Bl Healthcare, Inc. →