510(k) Report

FDA applicant

Cardiodynamics International Corp.

San Diego, CA11 decisions1996–20090 recalls

FDA records 11 decisions for Cardiodynamics International Corp. (San Diego, CA) from 1996 to 2009: 11 510(k) clearances. All are in product code DSB (Plethysmograph, Impedance). Its devices cite 14 predicates, 9 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 Cardiodynamics International Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 12009: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardiodynamics International Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardiodynamics International Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DSBPlethysmograph, Impedance11decisions

Whose devices does it build on?

Its devices cite 14 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 9 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.

  • K070156Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp. · 20073cite it
  • K041294Biozdx Hemodynamic MonitorCardiodynamics International Corp. · 20043cite it
  • K011439Modification to Bioz.Com Hemodynamic MonitorCardiodynamics International Corp. · 20013cite it
  • K974725Bioz.Com SystemCardiodynamics International Corp. · 19983cite it
  • K051228Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp. · 20052cite it
  • K001081Bioz.PC Hemodynamic Monitor Model BZ-500/BZ-501; Bioz.PC User Software Installation Kit Model BZ-810Cardiodynamics International Corp. · 20002cite it

What has FDA decided for it lately?

  • K090602Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp. · 2009
  • K070156Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp. · 2007
  • K051228Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp. · 2005
  • K041294Biozdx Hemodynamic MonitorCardiodynamics International Corp. · 2004
  • K011439Modification to Bioz.Com Hemodynamic MonitorCardiodynamics International Corp. · 2001
  • K011797Bioztect Sensor and Bioztect CableCardiodynamics International Corp. · 2001
  • K001081Bioz.PC Hemodynamic Monitor Model BZ-500/BZ-501; Bioz.PC User Software Installation Kit Model BZ-810Cardiodynamics International Corp. · 2000
  • K001100Bioz.Com Hemodynamic Monitor with Bioz Tect Sensor and Bioz Tect Cable Impedance PlethysmographCardiodynamics International Corp. · 2000

All 11 as Cardiodynamics International Corp. →