510(k) Report

FDA applicant

Biomedical Dynamics, Inc.

Burnsville, MN10 decisions1985–19921 recall

FDA records 10 decisions for Biomedical Dynamics, Inc. (Burnsville, MN) from 1985 to 1992: 10 510(k) clearances. Most are in product codes KZD (Infusor, Pressure, For I.V. Bags) and DXQ (Blood Pressure Cuff). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Biomedical Dynamics, Inc. since 2007.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Biomedical Dynamics, 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?

  • KZDInfusor, Pressure, For I.V. Bags3decisions
  • DXQBlood Pressure Cuff2decisions
  • FPASet, Administration, Intravascular1decision
  • FCYBulb, Inflation, For Endoscope1decision
  • KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration1decision
  • KPEContainer, I.V.1decision

Also: HMX (1).

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.

  • K911213CuffableBiomedical Dynamics, Inc. · 19914cite it

What has FDA decided for it lately?

  • K915074Irrigator/Aspirator ProbeBiomedical Dynamics, Inc. · 1992
  • K913751Pressure InfuserBiomedical Dynamics, Inc. · 1992
  • K911213CuffableBiomedical Dynamics, Inc. · 19911 recall
  • K911216InfusableBiomedical Dynamics, Inc. · 1991
  • K911324Irrigation/Aspiration Tubing SetBiomedical Dynamics, Inc. · 1991
  • K904376Aneroid Blood Pressure GaugeBiomedical Dynamics, Inc. · 1990
  • K890268Pressure Infusor for I.V. Bags/AutoinflationBiomedical Dynamics, Inc. · 1989
  • K881799Blood Pressure CuffBiomedical Dynamics, Inc. · 1988

All 10 as Biomedical Dynamics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K911213Cuffable Blood Pressure Cuffs; Manufactured for Vital Signs, Inc., a GE Healthcare…Apr 26, 2011