# K041691: Clip 'N'ject Reconstitution System (Clip 'N'ject

- Pathway: 510(k) (Traditional)
- Applicant: West Pharmaceutical Services, Inc.
- Decided: Aug 5, 2004 after 44 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). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010703: Inter-Vial, Duoject Medical Systems, Inc. (2001) Summary page 1.
- K963012: Bioject Needle-Free Vial Adapter (13MM), Bioject, Inc. (1996) Summary page 1.
- K963583: Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Preattached Needle, Medimop Medical Projects, Ltd. (1996). Our reading of the summary gave K963853, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Mixject”. Summary page 3.

## 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

## Indications for use
The Clip'n'Ject Reconstitution System is a single use device intended to transfer diluent into a vial containing a lyophilized drug, mix the diluent and the lyophilized drug, and transfer the reconstituted drug into a standard syringe. The Clip'n'Ject Reconstitution System may be used by physicians, nurses, and other practitioners who routinely administer injections, or by patients and other individuals authorized by their physician to administer injections of prescribed medication.

Source page: https://510kreport.com/device/K041691
Methodology: https://510kreport.com/methodology