510(k) Report

FDA applicant

Pointcare Technologies, Inc.

North Attleboro, MA2 decisions2004–20081 recall

FDA records 2 decisions for Pointcare Technologies, Inc. (North Attleboro, MA) from 2004 to 2008: 2 510(k) clearances. All are in product code GKZ (Counter, Differential Cell). Its devices cite 8 predicates, 1 of them its own earlier devices. 1 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 Pointcare Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Pointcare Technologies, 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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Which product codes does it file in?

  • GKZCounter, Differential Cell2decisions

Whose devices does it build on?

Its devices cite 8 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.

  • K041882Flowcare SystemPointcare Technologies, Inc. · 20041cites it

What has FDA decided for it lately?

  • K072869Pointcare Now SystemPointcare Technologies, Inc. · 20081 recall
  • K041882Flowcare SystemPointcare Technologies, Inc. · 2004

All 2 as Pointcare Technologies, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K072869PointCare NOW CD4NOW Gold Reagent Pack, or Gold Pack, Part Number :30034 In Vitro…Nov 2, 2011