# K052195: EZ-Mio Manual Driver

- Pathway: 510(k) (Traditional)
- Applicant: Vidacare Corporation
- Decided: Nov 2, 2005 after 83 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K915409 (1992). 6 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032885: Vidaport Intraosseous Infusion System, Vidacare Corporation (2004) Summary page 1.
- K043490: PD-IO Disposable Intraosseous Infusion Needle, Vidacare Corporation (2005) Summary page 1.

## Most influential descendants
- K080865: FAST1 Intraosseous Infusion System (2008), 3 descendants of its own
- K062956: EZ-Mio, EZ-IO Distal Tibia (2006), 3 descendants of its own
- K100124: Fastx Sternal Intraosseous Device (2010), 2 descendants of its own
- K091140: EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IO (2009), 2 descendants of its own
- K190538: NIO-I (2019), 1 descendant of its own

## Indications for use
For pediatric use: The PD-IOTM infusion system provides intraosseous access in proximal tibia, as an alternative to IV access during emergencies to pediatric patients, from birth to 21 years of age (approximate weight range: 3 kg - 39 kg). For adult use: The EZ-IOTM Infusion System provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies to adult patients (22 years of age or older, > 40 kg)

Source page: https://510kreport.com/device/K052195
Methodology: https://510kreport.com/methodology