# K160805: NIO-P

- Pathway: 510(k) (Traditional)
- Applicant: Waismed, Ltd.
- Decided: Jun 23, 2016 after 92 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.
1 later device descends from it; 1 cites it directly.
0 of 7 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.

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

## Recalls of this device
- Aug 18, 2016 · Class II · Z-2680-2016: WaisMed received a report in which during the operation of the NIO-A, the needle was not released from the device as expected. The device was placed on the floor and after several minutes the needle w

## Indications for use
The NIO-P for Pediatrics 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 between 3 and 12 years of age.

Source page: https://510kreport.com/device/K160805
Methodology: https://510kreport.com/methodology