# K063180: Isecure Syringe Cartridge Holder

- Pathway: 510(k) (Special)
- Applicant: Hospira, Inc.
- Decided: Dec 11, 2006 after 53 days
- Product code: IQG (Adaptor, Holder, Syringe)
- Device class: 1
- Regulation: 21 CFR 890.5050
- 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 K820164 (1982). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820164: Empty Sterile Carpuject, Sterling Drug, Inc. (1982) Summary page 1.

## Most influential descendants
- K180345: Uroject12 Syringe Lever (2018), 2 descendants of its own
- K190987: Uroject12 Syringe Lever (2019), 1 descendant of its own
- K083583: Xpresse Injection System (2009), 1 descendant of its own
- K203321: Cystoject Syringe Lever (2020), 0 descendants of its own
- K131963: Tautona Injector Device (2013), 0 descendants of its own

## Indications for use
The iSecure Syringe Cartridge Holder is intended for use in the withdrawal and administration of sterile materials under aseptic conditions in accordance with the best judgment of the physician.

Source page: https://510kreport.com/device/K063180
Methodology: https://510kreport.com/methodology