FDA applicant

Simplicity Diagnostics, Inc.

Hatboro, PA5 decisions1992–19970 recalls

FDA records 5 decisions for Simplicity Diagnostics, Inc. (Hatboro, PA) from 1992 to 1997: 5 510(k) clearances. Most are in product codes DHR (System, Test, Rheumatoid Factor) and DCK (C-Reactive Protein, Antigen, Antiserum, And…). 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Simplicity Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Simplicity Diagnostics, 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

Other applicant names beginning “Simplicity”

FDA records each applicant name separately; these may or may not be the same firm.

Simplicity Orthopedic Solutions, LLC 1

Simplicity Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Simplicity”