# K211968: NIO+ Adult

- Pathway: 510(k) (Special)
- Applicant: Waismed, Ltd.
- Decided: Jul 22, 2021 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: 5 generations back to K981853 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142086: Nio -Intraosseous Device, Waismed, Ltd. (2014) Summary page 4.

## Recalls of this device
- Jun 5, 2025 · Class II · Z-2119-2025: 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 (I10) access in the proximal tibia and the humeral head as an alternative to emergency IV access. Per urgent medical necessity, humeral head IO access may be used when rapid fluid or pharmacological resuscitation is required. The device is intended for use in adult patients only.

Source page: https://510kreport.com/device/K211968
Methodology: https://510kreport.com/methodology