510(k) Report

FDA applicant

Qardio, Inc.

San Fransciso, CA3 decisions2014–20220 recalls

FDA records 3 decisions for Qardio, Inc. (San Fransciso, CA) from 2014 to 2022: 3 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and DSH (Recorder, Magnetic Tape, Medical). Its devices cite 4 predicates, 1 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 Qardio, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2014: 12021: 12022: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Qardio, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions
  • DSHRecorder, Magnetic Tape, Medical1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K140067QardioarmQardio, Inc. · 20142cite it
  • K201644QardioCoreQardio, Inc. · 20211cites it

What has FDA decided for it lately?

  • K220106QardioArm 2Qardio, Inc. · 2022
  • K201644QardioCoreQardio, Inc. · 2021
  • K140067QardioarmQardio, Inc. · 2014

All 3 as Qardio, Inc. →