# K081436: Invirostripe 3ML, 5ML, 10ML Luer Lock Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Inviro Medical Devices, Inc.
- Decided: Oct 22, 2008 after 154 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: 2 generations back to K042102 (2005). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050999: YI Xin Sterile Syringe for Single Use, Jiangxi Sanxin (Eversincere) Medical Devices Group (2005) Summary page 1.

## Most influential descendants
- K101359: Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML) (2010), 1 descendant of its own
- K222744: Sol-M Luer Lock Syringe (2022), 0 descendants of its own

## Indications for use
The InviroStripe 3, 5 and 10 ml Standard Luer Lock Syringes are used to inject medicines into, or withdraw fluids from the body.

Source page: https://510kreport.com/device/K081436
Methodology: https://510kreport.com/methodology