# K981140: Minrad DRTS Light Saber Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Minrad, Inc.
- Decided: Jun 25, 1998 after 87 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Single use disposable syringe to inject fluids into, or retract fluids from the body When used with the DRTS™ Laser Alignment System, the Light Saber™ Syringe will provide an accuracy of +/- 3mm from the laser path when using a 10 cm needle.

Source page: https://510kreport.com/device/K981140
Methodology: https://510kreport.com/methodology