# K130179: MP Vial Adapter 13MM

- Pathway: 510(k) (Traditional)
- Applicant: Medimop Medical Projects, Ltd.
- Decided: Aug 8, 2013 after 195 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K963583 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122023: Mixject with Spray Head, Medimop Medical Projects, Ltd. (2012) Summary page 2.
- K963583: Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Preattached Needle, Medimop Medical Projects, Ltd. (1996) Summary page 2.
- K043304: Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01, Bioject Medical Technologies, Inc. (2005) Summary page 2.

## Indications for use
Allow needle-free withdrawal, reconstitution and transfer of Bravelle® (urofolitropin for injection, purified) and/or Menopur® (menotropins for injection, USP) and diluent from vials into an injection syringe for administration on a single patient during a single procedure.

Source page: https://510kreport.com/device/K130179
Methodology: https://510kreport.com/methodology