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The Tracker / October 2026 / K260530

510(k) cleared

epi-ConneKt Wound Matrix

MLM Biologics, Inc. · Oct 15, 2026 · K260530

FDA cleared the epi-ConneKt Wound Matrix from MLM Biologics, Inc. on Oct 15, 2026 under K260530, a traditional 510(k). The device falls under product code KGN, Wound Dressing With Animal-Derived Material(S) as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Feb 17, 2026. The decision came 240 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for MLM Biologics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260530?

K260530 is the FDA 510(k) for epi-ConneKt Wound Matrix, submitted by MLM Biologics, Inc.. FDA's decision date was Oct 15, 2026, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the epi-ConneKt Wound Matrix?

MLM Biologics, Inc., based in Alachua, FL, is the applicant of record for K260530.

How long did the K260530 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Oct 15, 2026, 240 days later.

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