510(k) Report

FDA applicant

Bowen Medical Services, Inc.

Live Oak, FL1 decision1995–19950 recalls

FDA records 1 decision for Bowen Medical Services, Inc. (Live Oak, FL) in 1995: 1 510(k) clearance. 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 Bowen Medical Services, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bowen Medical Services, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bowen Medical Services, 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 Cuff1decision

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.

  • K952825Cuff GuardBowen Medical Services, Inc. · 19952cite it

What has FDA decided for it lately?

  • K952825Cuff GuardBowen Medical Services, Inc. · 1995

The one decision as Bowen Medical Services, Inc. →

Other applicant names beginning “Bowen”

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

Bowen & Company, Inc. 14