# K182770: Adult Intraosseous Infusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Einstein Works, LLC
- Decided: Apr 9, 2019 after 193 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K191258: Intraosseous infusion device (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K182770
Methodology: https://510kreport.com/methodology