FDA applicant

R2 Diagnostics, Inc.

South Bend, IN10 decisions2004–20110 recalls

FDA records 10 decisions for R2 Diagnostics, Inc. (South Bend, IN) from 2004 to 2011: 10 510(k) clearances. Most are in product codes GJT (Plasma, Coagulation Factor Deficient) and GGW (Test, Time, Partial Thromboplastin). Its devices cite 11 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, hematology panel, where it files most

How often FDA has decided R2 Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2007high 2 (2010) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — R2 Diagnostics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like R2 Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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R2 Diagnostics, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?