510(k) K252663

Inbentus Versatile by Iconic Solutions by Murcia, SL — Product Code CBK

K252663 is an FDA 510(k) premarket notification submitted by Iconic Solutions by Murcia, SL for the device "Inbentus Versatile". The FDA issued a decision of Substantially Equivalent on April 14, 2026. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2026
Date Received
August 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type