# K101359: Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML)

- Pathway: 510(k) (Special)
- Applicant: Inviro Medical Devices, Inc.
- Decided: Aug 20, 2010 after 98 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K042102 (2005). 3 ancestors in all.
1 later device descends 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)
- K081436: Invirostripe 3ML, 5ML, 10ML Luer Lock Syringes, Inviro Medical Devices, Inc. (2008) Summary page 2.

## Most influential descendants
- K222744: Sol-M Luer Lock Syringe (2022), 0 descendants of its own

## Recalls of this device
- Jan 15, 2020 · Class II · Z-1453-2020: Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a need

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

Source page: https://510kreport.com/device/K101359
Methodology: https://510kreport.com/methodology