510(k) Report

FDA applicant

Dailycare Biomedical, Inc.

Chungli, TW5 decisions2005–20180 recalls

FDA records 5 decisions for Dailycare Biomedical, Inc. (Chungli, TW) from 2005 to 2018: 5 510(k) clearances. All are in product code DPS (Electrocardiograph). Its devices cite 6 predicates, 4 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 Dailycare Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007: 12018: 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 — Dailycare Biomedical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dailycare Biomedical, 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?

  • DPSElectrocardiograph5decisions

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 4 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.

  • K042814ReadmyheartDailycare Biomedical, Inc. · 20055cite it
  • K050620Readmyheart, Model RMH3.0Dailycare Biomedical, Inc. · 20053cite it
  • K052303Readmyheart, Model RMH2.0Dailycare Biomedical, Inc. · 20053cite it
  • K062894Instantcheck RTD-Ecg Monitor, Model RMH4.0Dailycare Biomedical, Inc. · 20071cites it

What has FDA decided for it lately?

  • K172778CheckMyHeart PlusDailycare Biomedical, Inc. · 2018
  • K062894Instantcheck RTD-Ecg Monitor, Model RMH4.0Dailycare Biomedical, Inc. · 2007
  • K052303Readmyheart, Model RMH2.0Dailycare Biomedical, Inc. · 2005
  • K050620Readmyheart, Model RMH3.0Dailycare Biomedical, Inc. · 2005
  • K042814ReadmyheartDailycare Biomedical, Inc. · 2005

All 5 as Dailycare Biomedical, Inc. →