510(k) Report

FDA applicant

JLK, Inc.

Seoul, KR8 decisions2024–20260 recalls

FDA records 8 decisions for JLK, Inc. (Seoul, KR) from 2024 to 2026: 8 510(k) clearances. Most are in product codes QAS (Radiological Computer-Assisted Triage And…) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 84 days from receipt to decision, against 131 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 0 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 JLK, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2024: 42025: 32026 (partial year): 1
2024high 4 (2024) · low 3 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — JLK, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like JLK, 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?

  • QASRadiological Computer-Assisted Triage And Notification Software4decisions
  • LLZSystem, Image Processing, Radiological3decisions
  • QIHAutomated Radiological Image Processing Software1decision

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 84 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 131 days; 5 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

All 8 as JLK, Inc. →