# K082674: Spectra-Glass Lor (Loss of Resistance Syringe, 5CC Metal L/S or L/L Tip, Spectra-Glass Lor (Loss of Resistance) Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Spectra Medical Devices, Inc.
- Decided: Nov 28, 2008 after 74 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K122416: Artiglass L. O.R. Glass Syringe (2013), 1 descendant of its own
- K213800: Artiglass NRFitTM Tip L.O.R. Glass Syringes (2022), 0 descendants of its own

## Indications for use
The Spectra, "GLASS LOR SYR1NGE" [Loss of Resistance 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/K082674
Methodology: https://510kreport.com/methodology