510(k) Report

FDA applicant

Statcorp, Inc.

Franklin, TN2 decisions1994–19960 recalls

FDA records 2 decisions for Statcorp, Inc. (Franklin, TN) from 1994 to 1996: 2 510(k) clearances. All are in product code DXQ (Blood Pressure Cuff). 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 Statcorp, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Statcorp, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Statcorp, 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?

  • DXQBlood Pressure Cuff2decisions

Who builds on its devices?

Later devices cite its devices 6 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.

  • K940214Statcorp Inc. Disposable Blood Pressure CuffStatcorp, Inc. · 19944cite it
  • K954282Ultracuff Blood Pressure Cuff and Inflation BagStatcorp, Inc. · 19962cite it

What has FDA decided for it lately?

  • K954282Ultracuff Blood Pressure Cuff and Inflation BagStatcorp, Inc. · 1996
  • K940214Statcorp Inc. Disposable Blood Pressure CuffStatcorp, Inc. · 1994

All 2 as Statcorp, Inc. →

Other applicant names beginning “Statcorp”

FDA records each applicant name separately; these may or may not be the same firm.

Statcorp Medical 2