FDA applicant

Livsmed, Inc.

Seongnam-Si, KR12 decisions2020–20250 recalls

FDA records 12 decisions for Livsmed, Inc. (Seongnam-Si, KR) from 2020 to 2025: 12 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GCJ (Laparoscope, General & Plastic Surgery). Since 2016 its 510(k)s took a median of 96 days from receipt to decision, against 109 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 9 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2025

2020high 3 (2020) · low 1 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Livsmed, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Livsmed, Inc.’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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Livsmed, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?