# K111467: Flexi-Q DV and DVR Auto-Injectors

- Pathway: 510(k) (Traditional)
- Applicant: Elcam Medical Acal
- Decided: Feb 9, 2012 after 259 days
- Product code: KZH (Introducer, Syringe Needle)
- Device class: 2
- Regulation: 21 CFR 880.6920
- 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 K945660 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001293: Modification to Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Pre-Attached Needle, Medimop Medical Projects, Ltd. (2000) Summary page 2.
- K013362: Autoject 2, Owen Mumford USA, Inc. (2001) Summary page 3.

## Indications for use
The Flexi-Q DV Auto-injector is indicated for the transfer and automated subcutaneous injection of FDA approved drugs and biologics in compatible vials. The Flexi-Q DV Auto-injector is intended for use in the home environment by the patient or care-giver after training by a Health Care Professional.

Source page: https://510kreport.com/device/K111467
Methodology: https://510kreport.com/methodology