# K191258: Intraosseous infusion device

- Pathway: 510(k) (Traditional)
- Applicant: Einstein Works, LLC
- Decided: Oct 23, 2019 after 166 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: 6 generations back to K981853 (1998). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160805: NIO-P, Waismed, Ltd. (2016) Summary page 4.
- K182770: Adult Intraosseous Infusion Device, Einstein Works, LLC (2019) Summary page 4.

## Indications for use
The NIO-P for pediatric is intended to provide Intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients in age 3-12 years of age.

Source page: https://510kreport.com/device/K191258
Methodology: https://510kreport.com/methodology