510(k) Report

FDA applicant

Top Spins, Inc.

Ann Arbor, MI3 decisions1997–20160 recalls

FDA records 3 decisions for Top Spins, Inc. (Ann Arbor, MI) from 1997 to 2016: 3 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and KCY (Tourniquet, Pneumatic). 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2016

2007: 12016: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Top Spins, Inc. 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?

  • FPASet, Administration, Intravascular2decisions
  • KCYTourniquet, Pneumatic1decision

What has FDA decided for it lately?

  • K151250Smart SetTop Spins, Inc. · 2016
  • K071140Mri Compatible Thigh Tourniquet, Model C070002Top Spins, Inc. · 2007
  • K972663Smart SetTop Spins, Inc. · 1997

All 3 as Top Spins, Inc. →