# K071027: Triboglide Lubricated Silicone-Free Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Tribofilm Research, Inc.
- Decided: Jul 20, 2007 after 100 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 K811065 (1981). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811065: Piston Syringe, Sherwood Medical Co. (1981) Summary page 1.
- (no number) Kendall Monoject Piston Syringes: named in the summary without a submission number

## Indications for use
The TriboGlideTM Lubricated Silicone-Free Syringe when combined with an appropriate gauge needle is used to inject fluids into, or withdraw fluids from, the body.

Source page: https://510kreport.com/device/K071027
Methodology: https://510kreport.com/methodology