# K181374: NRFit Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Caina Medical Co.,Ltd
- Decided: Dec 14, 2018 after 204 days
- Product code: QEH (Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact  )
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931367 (1993). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170218: Vesco Medical NRFit Tip Syringes, Vesco Medical, LLC (2017) Summary page 5.

## Indications for use
The device is indicated for local administration, and regional administration, specifically, wound infiltrations, peripheral nerve block, and epidural block. The device is not indicated for subarachnoid/spinal blocks.

Source page: https://510kreport.com/device/K181374
Methodology: https://510kreport.com/methodology