# K041564: Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01

- Pathway: 510(k) (Traditional)
- Applicant: Bioject Medical Technologies, Inc.
- Decided: Jul 16, 2004 after 36 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 K894177 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963012: Bioject Needle-Free Vial Adapter (13MM), Bioject, Inc. (1996) Summary page 2.
- K010623: Reconstitution Kit & Vial Connector, Bioject, Inc. (2001) Summary page 2.

## Indications for use
The Q.Cap™ Needle-Free Reconstitution 13mm Vial Adapter is intended to allow needle-free withdrawal, reconstitution and transfer of Repronex® (menotropins for injection, USP) and/or Bravelle® (urofollitropin for injection, purified) and diluent from vials into an injection syringe for administration.

Source page: https://510kreport.com/device/K041564
Methodology: https://510kreport.com/methodology