# K081524: Spectra-Lor, 10 ML Plastic Loss of Resistance Syringe, L/S, Spectra-Lor, 10ML Plastic Loss of Resistance Syringe L/L

- Pathway: 510(k) (Traditional)
- Applicant: Spectra Medical Devices, Inc.
- Decided: Jul 29, 2008 after 57 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 K001731 (2000). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001731: Avid-Nit Loss of Resistance Syringe, Avid Medical, Inc. (2000) Summary page 1.

## Most influential descendants
- K170900: DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories (2017), 1 descendant of its own
- K201031: NRFit® Caps, Male and Female Neuraxial Tip Caps (2020), 0 descendants of its own

## Indications for use
The "SPECTRA - LOR", 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/K081524
Methodology: https://510kreport.com/methodology