# K252663: Inbentus Versatile

- Pathway: 510(k) (Traditional)
- Applicant: Iconic Solutions by Murcia, SL
- Decided: Apr 14, 2026 after 235 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K902859 (1991). 123 ancestors in all.
No later device cites it as a predicate yet.
15 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201658: Hamilton-C6, Hamilton Medical AG (2020) Summary page 4.

## Indications for use
The INBENTUS VERSATILE ventilator is intended to provide invasive and noninvasive ventilatory support to adult, pediatric, and neonatal patients. It is only intended for use by qualified health care personnel, within professional hospital facilities and to transport patients within those facilities.

Source page: https://510kreport.com/device/K252663
Methodology: https://510kreport.com/methodology