FDA 510(k)

JLK-AILink

K-Number: K250348 · 2025-02-25

Decision Date2025-02-25

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

JLK-AILink is the device name listed in this FDA 510(k) record. The listed applicant is JLK, Inc.. It received FDA 510(k) clearance on 2025-02-25 under 510(k) number K250348. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JLK-AILink?

JLK-AILink is a medical device that received FDA 510(k) clearance on 2025-02-25. The listed applicant is JLK, Inc.. The 510(k) number is K250348.

When did JLK-AILink receive FDA 510(k) clearance?

JLK-AILink received FDA 510(k) clearance on 2025-02-25, under 510(k) number K250348.

Who is the listed applicant for JLK-AILink?

The FDA 510(k) record lists JLK, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JLK-AILink?

The FDA product code for JLK-AILink is LLZ.

Other records listing JLK, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252421JLK-NCCT K243611JLK-SDH K243363JLK-ICH K242709JLK-PWI K242556JLK-CTP K241480JBS-LVO

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.