# K141117: EZ-IO Intraosseous Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Vidacare, LLC
- Decided: Jul 8, 2014 after 69 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K132638: Dimension Creatinine (CRE2) Flex Reagent Cartridge, Siemens Healthcare Diagnostics, Inc. (2014). Our reading of the summary gave K132638, FDA’s number for Dimension Creatinine (CRE2) Flex Reagent Cartridge (Siemens Healthcare Diagnostics, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “EZ-IO Intraosseous Infusion System”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K180395: EZ-IO Intraosseous Vascular Access System (2018), 3 descendants of its own
- K191976: Piper GO-IO Intraosseous Infusion System (2019), 2 descendants of its own
- K202492: EZ-IO Intraosseous Vascular Access System (2021), 1 descendant of its own
- K203193: BD Intraosseous Infusion System (2021), 1 descendant of its own
- K191488: SAM IO Intraosseous Access System (2019), 1 descendant of its own

## Recalls of this device
- Oct 8, 2019 · Class II · Z-0688-2020: The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, 
- Oct 8, 2019 · Class II · Z-0689-2020: The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, 
- Oct 8, 2019 · Class II · Z-0690-2020: The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, 

## Indications for use
The EZ-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adults and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

Source page: https://510kreport.com/device/K141117
Methodology: https://510kreport.com/methodology