510(k) Report

FDA applicant

Statspin Technologies

Norwood, MA4 decisions1989–19901 recall

FDA records 4 decisions for Statspin Technologies (Norwood, MA) from 1989 to 1990: 4 510(k) clearances. Most are in product codes JKA (Tubes, Vials, Systems, Serum Separators, Blood…) and JPI (Device, Hematocrit Measuring). 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, clinical chemistry panel, where it files most

How often FDA has decided Statspin Technologies’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Statspin Technologies since 2007.

Recalls per year

1in 2008

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

Class I Class II/III not classified

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

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Which product codes does it file in?

  • JKATubes, Vials, Systems, Serum Separators, Blood Collection3decisions
  • JPIDevice, Hematocrit Measuring1decision

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.

  • K896206Statspin StatsamplerStatspin Technologies · 19892cite it

What has FDA decided for it lately?

  • K903698Statspin Micro-Hematocrit Reader for 75MM TubesStatspin Technologies · 1990
  • K896206Statspin StatsamplerStatspin Technologies · 19891 recall
  • K893613Statspin Mini-PlasmaStatspin Technologies · 1989
  • K884807Lipoclear Lipemia Clearing ReagentStatspin Technologies · 1989

All 4 as Statspin Technologies →

What has been recalled?

1 recall linked to its devices; the latest:

  • K896206StatSampler 200 uL, Li Heparin (micro blood collector) Ref: SS2H Packed in Catalog…Jun 20, 2008