# K122416: Artiglass L. O.R. Glass Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Artiglass Srl
- Decided: May 3, 2013 after 268 days
- Product code: FMF (Syringe, Piston)
- 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: 1 generation back to K082674 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082674: Spectra-Glass Lor (Loss of Resistance Syringe, 5CC Metal L/S or L/L Tip, Spectra-Glass Lor (Loss of Resistance) Syringe, Spectra Medical Devices, Inc. (2008) Summary page 1.

## Most influential descendants
- K213800: Artiglass NRFitTM Tip L.O.R. Glass Syringes (2022), 0 descendants of its own

## Indications for use
The Artigiass LOR 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 medical textbooks. These syringes are not intended for injection or aspiration.

Source page: https://510kreport.com/device/K122416
Methodology: https://510kreport.com/methodology
