510(k) Report

FDA applicant

Prucka Engineering, Inc.

Houston, TX6 decisions1989–20000 recalls

FDA records 6 decisions for Prucka Engineering, Inc. (Houston, TX) from 1989 to 2000: 6 510(k) clearances. Most are in product codes DRF (Catheter, Electrode Recording, Or Probe…) and DPS (Electrocardiograph). Its devices cite 3 predicates, 0 of them its own earlier devices. 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 Prucka Engineering, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Prucka Engineering, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Prucka Engineering, 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?

  • DRFCatheter, Electrode Recording, Or Probe, Electrode Recording2decisions
  • DPSElectrocardiograph2decisions
  • DRRAmplifier And Signal Conditioner, Biopotential1decision
  • DQKComputer, Diagnostic, Programmable1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K902716PE Electrophysiology Lab System (Peep)Prucka Engineering, Inc. · 19902cite it
  • K993414Prucka Engineering Inc. Cardiolab EP System,Version 4.2Prucka Engineering, Inc. · 20002cite it
  • K910307Cardiolab Amplifier Module (Cam)Prucka Engineering, Inc. · 19911cites it

What has FDA decided for it lately?

  • K993414Prucka Engineering Inc. Cardiolab EP System,Version 4.2Prucka Engineering, Inc. · 2000
  • K960321Cardiocath Catheterization Lab SystemPrucka Engineering, Inc. · 1996
  • K904747Pei Plaque Electrode ArrayPrucka Engineering, Inc. · 1991
  • K910307Cardiolab Amplifier Module (Cam)Prucka Engineering, Inc. · 1991
  • K902716PE Electrophysiology Lab System (Peep)Prucka Engineering, Inc. · 1990
  • K895916PE Intercardiac Mapping System (Icms)Prucka Engineering, Inc. · 1989

All 6 as Prucka Engineering, Inc. →