# K896381: MVP-10 Mri Infant Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Med Devices, Inc.
- Decided: Feb 12, 1990 after 98 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
No predicates in its family tree.
65 later devices descend from it; 2 cite it directly.
25 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K063404: Servo-I Ventilator System, Models 64, 87 and 800 (2007), 61 descendants of its own
- K081842: Engstrom Carestation, Engstrom Pro (2008), 37 descendants of its own
- K073179: Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 (2008), 28 descendants of its own
- K093886: Engstrom Carestation, Engstrom Pro (2010), 21 descendants of its own
- K103803: Hamilton-G5 (2011), 14 descendants of its own

Source page: https://510kreport.com/device/K896381
Methodology: https://510kreport.com/methodology