Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list JLK Inc. with 8 510(k) clearances and 5 AI-enabled devices. The most recent is a 510(k) clearance dated Mar 24, 2026: JLK-NCCT.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Mar 24, 2026 | JLK-NCCTK252421 · QAS | 510(k) clearances |
| Mar 24, 2026 | JLK-NCCTK252421 · Radiology | AI-enabled devices |
| Mar 3, 2025 | JLK-SDHK243611 · QAS | 510(k) clearances |
| Mar 3, 2025 | JLK-SDHK243611 · Radiology | AI-enabled devices |
| Feb 25, 2025 | JLK-AILinkK250348 · LLZ | 510(k) clearances |
| Jan 3, 2025 | JLK-ICHK243363 · QAS | 510(k) clearances |
| Jan 3, 2025 | JLK-ICHK243363 · Radiology | AI-enabled devices |
| Nov 4, 2024 | JLK-PWIK242709 · LLZ | 510(k) clearances |
| Oct 16, 2024 | JLK-CTPK242556 · LLZ | 510(k) clearances |
| Sep 27, 2024 | JBS-LVOK241480 · QAS | 510(k) clearances |
| Sep 27, 2024 | JBS-LVOK241480 · Radiology | AI-enabled devices |
| Jun 21, 2024 | Medihub ProstateK233196 · QIH | 510(k) clearances |
| Jun 21, 2024 | Medihub ProstateK233196 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
