510(k) Report

FDA applicant

Bg Medicine, Inc.

Waltham, MA1 decision2010–20100 recalls

FDA records 1 decision for Bg Medicine, Inc. (Waltham, MA) in 2010: 1 510(k) clearance. All are in product code OSX (Galectin-3 In Vitro Diagnostic Assay). Its devices cite 9 predicates, 0 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, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Bg Medicine, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bg Medicine, 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?

  • OSXGalectin-3 In Vitro Diagnostic Assay1decision

Whose devices does it build on?

Its devices cite 9 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K093758BGM Galectin -3Bg Medicine, Inc. · 20102cite it

What has FDA decided for it lately?

  • K093758BGM Galectin -3Bg Medicine, Inc. · 2010

The one decision as Bg Medicine, Inc. →