510(k) Report

FDA applicant

Symcare Personalized Health Solutions, Inc.

West Chester, PA2 decisions2009–20100 recalls

FDA records 2 decisions for Symcare Personalized Health Solutions, Inc. (West Chester, PA) from 2009 to 2010: 2 510(k) clearances. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 5 predicates, 1 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 Symcare Personalized Health Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2009: 12010: 1
2009high 1 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Symcare Personalized Health Solutions, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NBWSystem, Test, Blood Glucose, Over The Counter2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K083263Symcare Diabetes Management ProgramSymcare Personalized Health Solutions, Inc. · 20091cites it

What has FDA decided for it lately?

  • K093789Intouch DiabetesSymcare Personalized Health Solutions, Inc. · 2010
  • K083263Symcare Diabetes Management ProgramSymcare Personalized Health Solutions, Inc. · 2009

All 2 as Symcare Personalized Health Solutions, Inc. →