510(k) Report

FDA applicant

Unimom.Co

Osan-Si, KR4 decisions2018–20250 recalls

FDA records 4 decisions for Unimom.Co (Osan-Si, KR) from 2018 to 2025: 4 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). Since 2016 its 510(k)s took a median of 205 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 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 Unimom.Co’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018: 12019: 12024: 12025: 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

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

Planning a device like Unimom.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, Powered4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 205 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 147 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K190810OPERA, OPERA ecoUnimom.Co · 20193cite it
  • K242111VivaceUnimom.Co · 20251cites it
  • K180075MINUET LCD, MINUET LCD ecoUnimom.Co · 20181cites it

What has FDA decided for it lately?

  • K242111VivaceUnimom.Co · 2025
  • K232047VivaceUnimom.Co · 2024
  • K190810OPERA, OPERA ecoUnimom.Co · 2019
  • K180075MINUET LCD, MINUET LCD ecoUnimom.Co · 2018

All 4 as Unimom.Co →