510(k) Report

FDA applicant

D. E. Hokanson, Inc.

Bellevue, WA19 decisions1979–20040 recalls

FDA records 19 decisions for D. E. Hokanson, Inc. (Bellevue, WA) from 1979 to 2004: 19 510(k) clearances. Most are in product codes JOM (Plethysmograph, Photoelectric, Pneumatic Or…) 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 D. E. Hokanson, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for D. E. Hokanson, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — D. E. Hokanson, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like D. E. Hokanson, Inc.’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?

  • JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic5decisions
  • DPSElectrocardiograph2decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions
  • DXQBlood Pressure Cuff2decisions
  • JOBHexane Extraction, Fluorescence, Vitamin E1decision
  • DPTProbe, Blood-Flow, Extravascular1decision

Also: DXK (1), IYN (1), DSB (1), KNG (1), DQK (1), JEH (1).

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.

  • K973426Ans 2000 Ecg Monitor and Respiration PacerD. E. Hokanson, Inc. · 19983cite it
  • K982707EC6 PlethysmographD. E. Hokanson, Inc. · 19981cites it
  • K872517TL 400 Totalab Vascular Diagnostic SystemD. E. Hokanson, Inc. · 19871cites it

What has FDA decided for it lately?

  • K041689Polyurethane Blood Pressure CuffsD. E. Hokanson, Inc. · 2004
  • K033156OB1 Obstetrical DopplerD. E. Hokanson, Inc. · 2003
  • K023707A16 Blood Flow Measurement SystemD. E. Hokanson, Inc. · 2003
  • K982707EC6 PlethysmographD. E. Hokanson, Inc. · 1998
  • K973426Ans 2000 Ecg Monitor and Respiration PacerD. E. Hokanson, Inc. · 1998
  • K970570NIVP3 (Windows Version of NivpD. E. Hokanson, Inc. · 1997
  • K932852Non Invasive Vascular ProgramD. E. Hokanson, Inc. · 1994
  • K932812EC 5R PlethysmographD. E. Hokanson, Inc. · 1994

All 19 as D. E. Hokanson, Inc. →