510(k) Report

FDA applicant

Dao Health

Sacramento, CA3 decisions2012–20170 recalls

FDA records 3 decisions for Dao Health (Sacramento, CA) from 2012 to 2017: 3 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). Its devices cite 5 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Dao Health’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2012: 12013: 12017: 1
2012high 1 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Dao Health by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HGXPump, Breast, Powered3decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K111411Freemie (R)Dao Health · 20121cites it
  • K130349Freemie Breast Collection SystemDao Health · 20131cites it

What has FDA decided for it lately?

  • K172772Freemie Independence, Freemie LibertyDao Health · 2017
  • K130349Freemie Breast Collection SystemDao Health · 2013
  • K111411Freemie (R)Dao Health · 2012

All 3 as Dao Health →