# K190538: NIO-I

- Pathway: 510(k) (Traditional)
- Applicant: Waismed, Ltd.
- Decided: Oct 7, 2019 after 217 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: 4 generations back to K915409 (1992). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043490: PD-IO Disposable Intraosseous Infusion Needle, Vidacare Corporation (2005) Summary page 4.
- K052195: EZ-Mio Manual Driver, Vidacare Corporation (2005) Summary page 4.

## Most influential descendants
- K211395: NIO-I (2021), 0 descendants of its own

## Indications for use
The NIO-I is an Intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age.

Source page: https://510kreport.com/device/K190538
Methodology: https://510kreport.com/methodology