510(k) Report

FDA applicant

Chiaro Technology Limited

London, GB3 decisions2018–20240 recalls

FDA records 3 decisions for Chiaro Technology Limited (London, GB) from 2018 to 2024: 3 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 168 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.

FDA’s records also spell it “Chiaro Technology, Ltd.”.

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 Chiaro Technology Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018: 12021: 12024: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Chiaro Technology Limited by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Chiaro Technology Limited’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 90 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 168 days; 3 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 6 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.

  • K181863Elvie PumpChiaro Technology Limited · 20183cite it
  • K210936Elvie StrideChiaro Technology Limited · 20213cite it

What has FDA decided for it lately?

  • K242125Elvie Stride 2Chiaro Technology, Ltd. · 2024
  • K210936Elvie StrideChiaro Technology Limited · 2021
  • K181863Elvie PumpChiaro Technology Limited · 2018

All 2 as Chiaro Technology Limited →The one decision as Chiaro Technology, Ltd. →