510(k) Report

FDA applicant

Gould, Inc.

Mchenry, IL31 decisions1976–19917 recalls

FDA records 31 decisions for Gould, Inc. (Mchenry, IL) from 1976 to 1991: 31 510(k) clearances. Most are in product codes DRS (Transducer, Blood-Pressure, Extravascular) and DXG (Computer, Diagnostic, Pre-Programmed…). 7 recalls are 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 Gould, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gould, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gould, 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?

  • DRSTransducer, Blood-Pressure, Extravascular6decisions
  • DXGComputer, Diagnostic, Pre-Programmed, Single-Function4decisions
  • KRBProbe, Thermodilution4decisions
  • DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)3decisions
  • DQOCatheter, Intravascular, Diagnostic2decisions
  • DYGCatheter, Flow Directed2decisions

Also: DXN (1), DYB (1), CCK (1), DXJ (1), DRR (1), BZG (1).

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K830523Catheter Connection W/Integral InjectateGould, Inc. · 19831cites it

What has FDA decided for it lately?

  • K911935Cardiac Electrophysical Lead Selector, ModifiedGould, Inc. · 1991
  • K861092Model SP1465 Cardiac Output ComputerGould, Inc. · 1986
  • K860805Pressure Monitor Cath Models SP5325,SP5327,SP5337Gould, Inc. · 1986
  • K855145Model:TA-Rose Resonant Overshoot EliminatorGould, Inc. · 1986
  • K854403Model 2120 SpiroscreenGould, Inc. · 1986
  • K851486Gould Disposable Transducer & Accessories-DTXGould, Inc. · 1985
  • K850114C/Pes 9201, Ecg Stress Testing SysGould, Inc. · 1985
  • K850113C/Pes 9103, Ecg Stress Testing SystemGould, Inc. · 1985

All 31 as Gould, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K791844DTX (tm) Plus DT-DL60 Continuous flush catheterJul 1, 2005
  • K791844DT-DL60-1 W/BifurcatedJul 1, 2005
  • K791844CRITIFLO (tm) flush kit.Jul 1, 2005
  • K791844CRITIFLO (tm) FLUSH KITJul 1, 2005
  • K791844CRITIFLOW (tm) TA4004 continuous flush catheterJul 1, 2005
  • K791844TAKHPQ60R continuous flow catheter.Jul 1, 2005