# K213800: Artiglass NRFitTM Tip L.O.R. Glass Syringes

- Pathway: 510(k) (Special)
- Applicant: Artiglass Srl
- Decided: May 19, 2022 after 164 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: 2 generations back to K082674 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122416: Artiglass L. O.R. Glass Syringe, Artiglass Srl (2013) Summary page 4.

## Indications for use
The Artiglass NRFit tip Glass Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard textbooks. These syringes are not intended for injection or aspiration.

Source page: https://510kreport.com/device/K213800
Methodology: https://510kreport.com/methodology