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Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O. vs VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC: FDAPulse comparison

Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O.'s review days of 387 is 1.4x VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC's 270 (99th percentile). Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O. is dated 2026-09-19; VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC 2026-09-18.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

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How does Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O. compare to VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC?

FieldDynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O.VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC
Record510(k) clearance510(k) clearance
510(k) numberK252723K254160
DeviceDynamis Pro FamilyVacHeal Negative Pressure Wound Therapy System
ApplicantFotona D.O.O.VacHeal, LLC
Specialty / panelGeneral, Plastic SurgeryGeneral, Plastic Surgery
Product codeGEXOKO
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2025-08-282025-12-22
Decision date2026-09-192026-09-18
Review time (days)387270
Third-party reviewNoNo
Applicant locationLjubljana, SIArdmore, PA, US
amount percentile99th94th
Predicate Speed & CAPA Advisory Opportunity Score55/10055/100
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Official records: Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O. · VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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