# K142086: Nio -Intraosseous Device

- Pathway: 510(k) (Special)
- Applicant: Waismed, Ltd.
- Decided: Aug 28, 2014 after 28 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K981853 (1998). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981853: Bone Injection Gun (B.I.G.) Device, Waismed, Ltd. (1998) Summary page 4.
- K062940: Bone Injection Gun (B.I.G.), Waismed, Ltd. (2006) Summary page 4.

## Most influential descendants
- K160805: NIO-P (2016), 1 descendant of its own
- K211968: NIO+ Adult (2021), 0 descendants of its own
- K191258: Intraosseous infusion device (2019), 0 descendants of its own

## Recalls of this device
- Jun 5, 2025 · Class II · Z-2118-2025: Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.

## Indications for use
The NIO Adult is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only. The NIO Adult is indicated for use in providing intraosseous access as an alternative to IV access during emergencies. Humeral head access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible. The device is for use in adult patients only.

Source page: https://510kreport.com/device/K142086
Methodology: https://510kreport.com/methodology