510(k) Report

FDA applicant

Tsi, Inc.

St. Paul, MN4 decisions1985–19900 recalls

FDA records 4 decisions for Tsi, Inc. (St. Paul, MN) from 1985 to 1990: 4 510(k) clearances. All are in product code DPW (Flowmeter, Blood, Cardiovascular). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Tsi, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tsi, 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?

  • DPWFlowmeter, Blood, Cardiovascular4decisions

Who builds on its devices?

Later devices cite its devices 4 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.

  • K896515Laserflo Blood Perfusion Monitor, Model BPM2Tsi, Inc. · 19903cite it
  • K875179Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 19881cites it

What has FDA decided for it lately?

  • K896515Laserflo Blood Perfusion Monitor, Model BPM2Tsi, Inc. · 1990
  • K875179Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
  • K864259Modified Laserflo Blood Perfusion MonitorTsi, Inc. · 1987
  • K851057Laserflo Blood Perfusion Monitor 403Tsi, Inc. · 1985

All 4 as Tsi, Inc. →