510(k) Report

FDA applicant

Lunit, Inc.

Seoul, KR6 decisions2021–20260 recalls

FDA records 6 decisions for Lunit, Inc. (Seoul, KR) from 2021 to 2026: 6 510(k) clearances. Most are in product codes QDQ (Radiological Computer Assisted…) and QFM (Radiological Computer-Assisted Prioritization…). Since 2016 its 510(k)s took a median of 118 days from receipt to decision, against 154 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 4 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, radiology panel, where it files most

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

FDA decisions per year

1in 2024

2021: 22023: 12024: 12026 (partial year): 2
2021high 2 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

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

Planning a device like Lunit, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For…5decisions
  • QFMRadiological Computer-Assisted Prioritization Software For Lesions1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 118 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 154 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 4 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.

  • K211733Lunit INSIGHT CXR TriageLunit, Inc. · 20216cite it
  • K242652Lunit INSIGHT DBT v1.1Lunit, Inc. · 20242cite it
  • K211678Lunit INSIGHT MMGLunit, Inc. · 20212cite it
  • K231470Lunit INSIGHT DBTLunit, Inc. · 20231cites it

What has FDA decided for it lately?

  • K260320Lunit INSIGHT MMG (v1.1.10)Lunit, Inc. · 2026
  • K253796Lunit INSIGHT DBT (V1.2)Lunit, Inc. · 2026
  • K242652Lunit INSIGHT DBT v1.1Lunit, Inc. · 2024
  • K231470Lunit INSIGHT DBTLunit, Inc. · 2023
  • K211678Lunit INSIGHT MMGLunit, Inc. · 2021
  • K211733Lunit INSIGHT CXR TriageLunit, Inc. · 2021

All 6 as Lunit, Inc. →