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The Tracker / September 2026 / K254160

510(k) cleared

VacHeal Negative Pressure Wound Therapy System

VacHeal, LLC · Sep 18, 2026 · K254160

FDA cleared the VacHeal Negative Pressure Wound Therapy System from VacHeal, LLC on Sep 18, 2026 under K254160, a traditional 510(k). The device falls under product code OKO, Negative Pressure Wound Therapy Non-Powered Suction Apparatus, regulated at 21 CFR 878.4683 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 22, 2025. The decision came 270 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 VacHeal, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254160?

K254160 is the FDA 510(k) for VacHeal Negative Pressure Wound Therapy System, submitted by VacHeal, LLC. FDA's decision date was Sep 18, 2026, under product code OKO (Negative Pressure Wound Therapy Non-Powered Suction Apparatus).

Who makes the VacHeal Negative Pressure Wound Therapy System?

VacHeal, LLC, based in Ardmore, PA, is the applicant of record for K254160.

How long did the K254160 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on Sep 18, 2026, 270 days later.

← All decisions in September 2026