# K122023: Mixject with Spray Head

- Pathway: 510(k) (Traditional)
- Applicant: Medimop Medical Projects, Ltd.
- Decided: Oct 4, 2012 after 85 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 K963583 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963583: Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Preattached Needle, Medimop Medical Projects, Ltd. (1996) Summary page 1.
- 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 1.
- K002255: Laryngo-Tracheal Mucosal Atomization Device (Madgic), Wolfe Tory Medical, Inc. (2000) Summary page 1.

## Most influential descendants
- K130179: MP Vial Adapter 13MM (2013), 0 descendants of its own

## Indications for use
Transfer, mixing and topical spray application / delivery of drugs with a viscosity up to 4.7cP contained in vials

Source page: https://510kreport.com/device/K122023
Methodology: https://510kreport.com/methodology