Inbentus Versatile— 510(k) K252663
Substantially EquivalentIconic Solutions by Murcia, SL
FDA 510(k) clearance K252663 for Inbentus Versatile, Substantially Equivalent on 2026-04-14. Applicant: Iconic Solutions by Murcia, SL. Device class: 2.
Summary
Inbentus Versatile comes from Iconic Solutions by Murcia, SL and is filed under product code CBK (Ventilator, Continuous, Facility Use). The record doesn't describe the ventilator beyond its name and that code name.
Class II, 21 CFR 868.5895. It came in as a Traditional 510(k), and Anesthesiology is both the classification panel and the review panel.
Iconic Solutions by Murcia filed from Murcia, Spain. Review took 235 calendar days (August 22, 2025 to April 14, 2026).
Clearance details
- Applicant
- Iconic Solutions by Murcia, SL
- Product code
- Product code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murcia, ES
Recent devices under product code CBK
view allAdverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.