510(k) Report

FDA applicant

Imani Co.

Yongin-Si, KR3 decisions2021–20230 recalls

FDA records 3 decisions for Imani Co. (Yongin-Si, KR) from 2021 to 2023: 3 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). Since 2016 its 510(k)s took a median of 218 days from receipt to decision, against 240 for FDA’s reviews in the same codes and years. Its devices cite 3 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 Imani Co.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021: 22023: 1
2021high 2 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Imani Co. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Imani Co.’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 218 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 240 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 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.

  • K202045imani i1Imani Co. · 20211cites it
  • K202037imani i2Imani Co. · 20211cites it

What has FDA decided for it lately?

  • K222573imani i2Plus Breast PumpImani Co. · 2023
  • K202037imani i2Imani Co. · 2021
  • K202045imani i1Imani Co. · 2021

All 3 as Imani Co. →