510(k) Report

FDA applicant

Digital Cardiovascular Instruments, Inc.

Emeryville, CA1 decision1986–19860 recalls

FDA records 1 decision for Digital Cardiovascular Instruments, Inc. (Emeryville, CA) in 1986: 1 510(k) clearance. All are in product code DRO (Pacemaker, Cardiac, External Transcutaneous…). 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 Digital Cardiovascular Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Digital Cardiovascular Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Digital Cardiovascular Instruments, 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?

  • DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)1decision

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.

  • K854196Dci Model EP-2 Clinical StimulatorDigital Cardiovascular Instruments, Inc. · 19861cites it

What has FDA decided for it lately?

  • K854196Dci Model EP-2 Clinical StimulatorDigital Cardiovascular Instruments, Inc. · 1986

The one decision as Digital Cardiovascular Instruments, Inc. →