510(k) Report

FDA applicant

Philips Consumer Lifestyle - Innovation Site Eindhoven

Eindhoven, NL3 decisions2016–20200 recalls

FDA records 3 decisions for Philips Consumer Lifestyle - Innovation Site Eindhoven (Eindhoven, NL) from 2016 to 2020: 3 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 128 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 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 Philips Consumer Lifestyle - Innovation Site Eindhoven’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2016: 12020: 2
2016high 2 (2020) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Philips Consumer Lifestyle - Innovation Site Eindhoven by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Philips Consumer Lifestyle -…’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?

  • HGXPump, Breast, Powered3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 88 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 128 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K201381Philips Avent Single/Double electric breast pump AdvancedPhilips Consumer Lifestyle - Innovation Site Eindhoven · 20202cite it
  • K161532Philips Avent Comfort Single/Twin Electric Breast PumpPhilips Consumer Lifestyle - Innovation Site Eindhoven · 20161cites it

What has FDA decided for it lately?

  • K203383Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump…Philips Consumer Lifestyle - Innovation Site Eindhoven · 2020
  • K201381Philips Avent Single/Double electric breast pump AdvancedPhilips Consumer Lifestyle - Innovation Site Eindhoven · 2020
  • K161532Philips Avent Comfort Single/Twin Electric Breast PumpPhilips Consumer Lifestyle - Innovation Site Eindhoven · 2016

All 3 as Philips Consumer Lifestyle - Innovation Site Eindhoven →