# K043304: Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01

- Pathway: 510(k) (Traditional)
- Applicant: Bioject Medical Technologies, Inc.
- Decided: Jan 14, 2005 after 45 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
No predicates in its family tree.
4 later devices descend from it; 2 cite 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)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K041654: Q.Cap Needle-Free Reconstitution 13mm Vial Adapter. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K070584: Smart-Rod (2008), 2 descendants of its own
- K133097: E-Z Link (2014), 1 descendant of its own
- K161800: OnSite-IV (2016), 0 descendants of its own
- K130179: MP Vial Adapter 13MM (2013), 0 descendants of its own

## 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/or Menopur® (menotropins for injection, USP) and diluent from vials into an injection syringe for administration.

Source page: https://510kreport.com/device/K043304
Methodology: https://510kreport.com/methodology